Methods for the reproducible generation of defined bone fractures

Abstract

Method for producing a defined bone fracture with accompanying soft tissue injuries in a specimen (106) comprising bone and soft tissue mantle, wherein the soft tissue mantle is understood to mean all the body's own tissue surrounding the bone of a specimen (106), including muscles, ligaments, tendons, joint capsules, nerves, skin and vessels, wherein a device (100), (200) is used to carry out the method, which i. at least one guide column (118), (218), ii. at one end of the guide column (118), (218) a base plate (101), (201), iii. a crossbeam (109), (209) with stamp (111), (211), iv. at least one means (110), (210) for adjusting the damping upon impact of a defined mass, v. at least one clamping plate (107), (207) for fixing the specimen, vi. a mass (112), (212) and, if necessary, additional weight (113), (213) for setting the defined mass, vii. at least one further cross member (115), (215) with at least one releasable holding mechanism (114), (214) for positioning the defined mass and means for fixing the preparation (102), wherein shock absorbers are used as means for adjusting the damping on impact, characterized in that a defined force impulse is exerted on a fixed preparation (106) and the change in the length of the preparation (106) along the force vector is limited to a maximum of 80 mm by setting a defined compression and a defined damping by means of shock absorbers, wherein a) the defined bone fracture is a pilon fracture, b) a preparation (106) comprising or consisting of foot and lower leg is selected, c) a defined mass of 24.7 to 38.5 kg is set, d) the preparation (106) is aligned in a defined geometry with respect to the direction from which the defined mass impacts the preparation (106) when the holding mechanism (114), (214) is triggered, by means of means for fixing the preparation (102), e) the defined speed is set to 100 to 111 cm by means of the fall height of the defined mass, f) the defined compression is set to 30 to 51 mm with at least one shock absorber, g) the defined damping is set as the damped part of the defined compression to 0 to 25 mm, h) the holding mechanism (114), (214) is triggered, i) the preparation (106) is removed from the device (100), (200).

Description

[0001] The invention relates to a method for the reproducible generation of defined bone fractures with accompanying soft tissue injuries in specimens, particularly in human specimens, devices for applying the method, and the specimens produced by the method, particularly human specimens, which are characterized by a defined bone fracture with accompanying soft tissue injuries. The specimens produced by the method according to the invention, particularly human specimens, are applicable for the training, education, and continuing education of medical personnel, for the development and validation of medical devices, implants, and prostheses, for accident analyses, and expert opinions.

[0002] Surgical training and continuing education offers certified courses that provide practical training in surgical techniques. During the practical sessions, artificial bones or intact, uninjured human specimens serve as "practice patients." This creates a significant discrepancy between the situation in continuing education courses and the reality in the operating room. Therefore, the majority of surgical techniques can only be discussed theoretically.

[0003] Artificial bone does not have the same biomechanical properties as human bone. This means that screws, for example, offer a completely different hold in artificial bone than in human bone. Likewise, the varying bone qualities of patients play a major role in the type of treatment in everyday clinical practice. The choice of implants depends largely on genetic and age-related bone quality, as well as the inhomogeneous structure of the bone itself. Artificial bone cannot adequately represent these differences. For this reason, the handling of different medical technology products such as osteosynthesis materials, screws and implants, or work processes such as drilling and milling cannot be adequately practiced with the help of artificial bone. A further disadvantage is that soft tissues (skin, subcutaneous tissue, muscles, etc.) are not taken into account in the current course offerings.The operation is performed on the “bare” bone and the handling of the soft tissue, which is crucial for the postoperative result, cannot be taught with this method.

[0004] For this reason, training and continuing education courses are offered in which the practical components are carried out on human specimens. Although operations can be performed on human specimens with the soft tissue intact, the bones and surrounding soft tissue are intact. Osteosynthesis materials can only be applied to intact bone. This is trivial for advanced physicians. For this reason, the standards of this continuing education can be regarded as inadequate. To date, there are no specimens with realistic bone fractures, i.e. bone fractures with accompanying soft tissue injuries such as those that occur in real accidents. Realistic training and continuing education with realistic bone fractures and realistic soft tissue injuries is not currently possible.

[0005] In practice, attempts are made to compensate for the problem of the lack of bone fractures in human specimens by applying direct, invasive force to the specimen. The bone fractures are created by the participants themselves using tools such as saws, chisels, hammers, or surgical instruments. This requires the application of high levels of energy to the specimen. Current practice leads to collateral damage to the specimen and poor quality both in the resulting bone fractures and in the soft tissue surrounding the bone. Although this direct application of force usually allows the target area to be accurately targeted under visual control, the direction of the applied force does not correspond to the line of action in a real accident mechanism. The direct application of force opens the soft tissue envelope, and the soft tissue surrounding the bone is damaged massively and unrealistically.The resulting bone fractures therefore do not correspond to those in real bone fractures caused by indirect force. In particular, they differ in their geometry and the nature of the bone fragments involved from the typical fracture patterns that occur in a real accident. Furthermore, typical accompanying ligament injuries (to capsules, ligaments, and tendons) are not produced. The manual application of force with tools from non-standardized heights and angles leads to varying results in the specimen and is not standardized. The individuality of the specimens in terms of morphology and geometry is not taken into account.

[0006] The other methods known in the state of the art involve simple physical experiments in which high energies are applied to specimens. The questions always concerned how an injury occurs or how specimens react when exposed to a potential injury mechanism in a practical experiment.

[0007] Amis, A. and Miller, J. (1995), Injury Vol. 26, No. 3: 163-168 investigated the development of elbow fractures in 40 specimens in which the bone was surrounded by subcutaneous soft tissue. The bone was exposed at one end, encased in polymethacrylate bone cement, attached to a 60 kg mass, and suspended horizontally on two rods. The 60 kg mass was intended to simulate the inertial properties of the human torso. The injuries in the specimen were created using a deflectable pendulum with a mass of 20 kg, which impacted the specimen from various deflections. The prepared humeral shaft was fixed using an angle-adjustable device such that the flexion and extension movement of the elbow joint lay in the plane of movement of the pendulum. Force impulse tests were carried out at different elbow flexion and forearm rotation.The location of initial contact between the pendulum and the specimen could not be precisely determined, so both forearm bones were initially loaded simultaneously or only one. A distal radius fracture was induced with a hit rate of 37.5% at flexion angles of 0 to 80 degrees and force impulses of 0.3 to 6.1 kN. An ulna fracture was induced with a hit rate of 32.5% at flexion angles of 60 to 135 degrees and force impulses of 2.1 to 6.8 kN.

[0008] McGinley, J. et al. (2003) The Journal of Bone and Joint Surgery: 2403-2409 positioned human specimens in a vertical position relative to a gravitationally accelerated mass of 27 kg, which was dropped from a height of 90 cm onto the clamped specimens. After impact, the mass was decelerated by two springs to prevent crushing of the specimens. A proximal radial fracture with an accompanying distal ulnar fracture was created in the clamped specimens at a predetermined forearm rotation of 2, 4, 6, and 8 degrees (5 + / - 2.6 degrees). An isolated radial head fracture was created at a predefined forearm rotation of 40, 41, 42, 45, 50, and 53 degrees (44.4 + / - 5.2 degrees), and Essex-Lopresti fractures were created at a predefined forearm rotation of 51, 54, 58, 90, 108, and 110 degrees (70 + / - 25.2 degrees). A proximal radial fracture with concomitant distal ulna fracture was observed in 4 of 20 specimens (i.e.hit rate 20%), an isolated radial head fracture in 7 of 20 specimens (i.e. hit rate 35%), and an Essex-Lopresti fracture in 9 of 20 specimens (i.e. hit rate 45%). In the studies by McGinley et al., the soft tissues of the forearm were left untouched, but the hand was completely severed from the arm. A realistic fall onto the outstretched arm could therefore not be reproduced. Whether the generated fractures correspond to reality has not been verified. No specification regarding deformation or compression of the specimens by the device used was given.

[0009] McGinley, J. et al. (2006) Skeletal Radiol. 35: 275-281 investigates the injury patterns of the IOM (interosseous membrane) in human specimens.

[0010] In Delye, H. et al. (2007) Journal of Neurotrauma 24: 1576-1586, skull fractures were created on skull specimens without soft tissue mantle using a mechanical pendulum with a mass of 14.3 kg and a pendulum length of 128 cm.

[0011] Fitzpatrick, M. et al. (2012) J. Orthop Trauma, Vol. 0, No. 0: 1-6 examined specimens without a soft tissue envelope that were rotated, clamped in a machine, and compressed. The applied force served to test the failure limits of biological material and did not simulate a real trauma event. No defined fractures were created.

[0012] Masouros, S. et al. (2013) Annals of Biomedical Engineering, DOI: 10.1007 / s10439-013-0814-6 investigated the effect of an explosion on the lower extremity. Specimens were fixed in two different positions (standing and sitting) with the shod foot attached to the lid of a pressure cylinder. Gas was pumped into the cylinder until the pressure inside the cylinder was so great that the lid was explosively accelerated upwards against the specimen. In this study, various injuries were randomly created, but no specific fractures were deliberately produced.

[0013] Henderson, K. et al. (2013) "Biomechanical Response of the Lower Leg under High Rate Loading" (In: 2013IRCOBI Conference 2013 proceedings, 11-13 September 2013, Gothenburg (Sweden), pp. 145-157) also investigated the lower extremities in specimens without soft tissue coverings. The specimens were clamped in a device, and masses weighing between 38.5 and 61.2 kg were dropped onto the specimens from a height of 1 to 2.3 m, and the resulting fractures were examined.

[0014] Robert Holz, “The Mechanism of the Essex-Lopresti: Investigation of Tissue Failure Using a Newly Developed Simulator” (Cologne, German Sport University, Master's thesis, 2012), used a simulator with a gravitationally accelerated falling body to investigate the biomechanics and injury sequence of the Essex-Lopresti fracture. For this purpose, the human specimens were dissected free, i.e., the skin and subcutaneous tissue, including the muscles, were removed, and the arms were dissected free except for the IOM (interosseous membrane) and the joint capsules around the elbow and wrist. Holz describes the alignment and clamping of the specimen in the simulator, the optical analysis of the fracture creation, and the determination of the horizontal, vertical, and relative movement of the segments during fracture creation. Holz was able to create the Essex-Lopresti fracture in 4 out of 30 cases, i.e., with a hit rate of 13.3%, in specimens without a soft tissue covering.

[0015] Marc Ebinger's "Design and evaluation of a novel simulator for high-speed injuries of the human forearm" (Cologne, German Sport University, Master's thesis, 2013) presents a drop test rig for generating axial impact loads. Piezoelectric force sensors were used to record the force profile. The kinematics were recorded using three high-speed cameras. The test rig was used to create and analyze Essex-Lopresti, Monteggia, and Galeazzi injuries in human specimens without soft tissue. Ebinger recommends constructing adapters for future work to standardize specimen fixation, thus minimizing operator error.

[0016] Dieter Fink “Conception and creation of a software package for synchronization, data acquisition and measurement signal display for the Essex Lopresti simulator” (Cologne, German Sport University, Master’s thesis, 2012) reveals the selection of suitable measurement technology and methods of evaluating the measurement results to clarify and validate the injury sequence in the development of an Essex Lopresti in human specimens.

[0017] Wegmann, K. et al. (2014) Acta Orthopaedica; 85 (2): 177-180 investigated the development of Essex Lopresti in human specimens without soft tissue. For this purpose, the freely prepared bones were marked and bone fractures were created using a device with a gravitationally accelerated falling body. The injury process was analyzed using high-speed cameras.

[0018] US 2014 / 0 057 236 A1 concerns a surgical simulator, but does not disclose a defined fracture in a specimen or its manufacture.

[0019] Deborah R. Marth (2002) (dissertation "Biomechanics of the shoulder in lateral impact") examined the injuries sustained by twelve whole-body cadavers in a car accident following a side impact. The cadaver specimens were placed on a chair, strapped down, and the head was raised using a pulley system to maintain an upright position. Accelerometers were attached to the specimen at various anatomical corners without preloading the bone. The lateral impact was applied using a pneumatic machine in the form of a cylinder (23.4 kg). The center of the cylinder was centered on the acromion, visible from the laterally. The specimens were divided into two groups. One group (n=6) received the impact at a speed of 4.47 m / s (Group A), and the other (n=6) at 6.71 m / s (Group B).X-rays were taken and autopsies were performed for evaluation. In Group A, the most common injuries were rib fractures. In Group B, 5 of 6 specimens had either a clavicle fracture (exact location not disclosed) or an acromion fracture, as well as at least 4 rib fractures. With a cylinder velocity of 5.7 m / s, an impact force of 2916 N, and a deformation stiffness between the acromion and the T1 vertebra of 23%, the probability of a severe shoulder injury (AIS 2+) was 50%. Critical comments on the study design were made regarding the accuracy of the force impact in combination with the different anthropometric characteristics and soft tissue masses of the test specimens. Marth observed that the impact was not always the same, which is why the specimens exposed to the simulated accident scenario exhibited random injuries.

[0020] The bone fractures produced by the current technology are random products. No known methods are available that can specifically produce defined bone fractures.

[0021] Bone fractures can be divided into defined fracture classes. These defined bone fractures are similar in terms of their location and fracture pattern, or, when considering individual anatomical variations in accident victims, very similar. These defined bone fractures are also similar or very similar in terms of accompanying soft tissue injuries among individual accident victims.

[0022] Specimens with realistic bone fractures are needed for the development of better implants, prostheses, and osteosynthesis materials, as well as for better training of medical personnel. Physicians, especially surgeons, must demonstrate a certain number of operations to gain their qualifications and be allowed to perform operations independently. This is time-consuming and potentially harmful to the patients themselves due to "practicing on patients." Physicians participate in certified continuing education courses in which surgical treatments are practiced on human specimens. Currently, no courses with realistic bone fractures on the specimens exist.

[0023] Human specimens are body donations. For ethical reasons, there is a need for methods that can create defined, realistic bone fractures in the specimens with a high hit rate. Methods that create bone fractures randomly with a low probability are not suitable for commercial use for ethical reasons.

[0024] There is therefore a great need for methods that can be used to specifically and reproducibly produce defined bone fractures in human specimens. There is also a great need for the human specimens produced using these methods and their use in education and training, as well as in the medical technology industry.

[0025] These objects are achieved by the inventive methods and preparations according to patent claims 1 and 2.

[0026] The invention relates to a method for producing at least one defined bone fracture with accompanying soft tissue injuries in a specimen 106, characterized in that a defined force impulse is exerted on the fixed specimen 106 and the change in the length of the specimen 106 along the force vector is limited to a maximum of 80 mm. Preferably, the change in the length of the specimen 106 is limited to a maximum of 80 mm by setting a defined compression to which the specimen 106 is subjected during the force impulse. The defined bone fracture can be produced in the specimen 106 by the method according to the invention by a force impulse resulting from a kinetic energy of 5 to 500 joules.

[0027] The subject of the invention is a method for producing at least one defined bone fracture with accompanying soft tissue injuries in a preparation 106 by setting a defined compression comprising a) Selection of a defined bone fracture; b) Fixation of a preparation 106; c) setting a defined mass and positioning the defined mass with a holding mechanism 114, 214; d) setting a defined speed with which the defined mass impacts the preparation 106; e) setting a defined compression to which the specimen 106 is subjected upon impact of the defined mass when the holding mechanism 114, 214 is released; f) setting a defined damping to which the preparation 106 is exposed upon impact of the defined mass when the holding mechanism 114, 214 is released; g) triggering the holding mechanism 114, 214 to accelerate the defined mass towards the preparation 106; h) Removing the fixation of the specimen 106; wherein steps b) to f) can be performed in a variable order, and wherein the setting of a defined damping is optional. The change in the length of the specimen 106 along the force vector is limited to a maximum of 80 mm. This can be achieved by setting a defined compression.

[0028] The method according to the invention leads to the reproducible generation of a defined bone fracture with accompanying soft tissue injuries in a preparation 106 with a probability of at least 50%, preferably at least 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%.

[0029] In the method, the change in the length of the specimen 106 along the force vector is limited. Preferably, the reduction in the length of the specimen 106 is a maximum of 80 mm, for example, preferably a maximum of 65 mm, particularly preferably a maximum of 52 mm or less. The maximum compression of the specimen is 80 mm, preferably a maximum of 65 mm, particularly preferably a maximum of 52 mm. The defined compression that the specimen experiences upon impact with the mass is a maximum of 80 mm, preferably 1 mm to 60 mm, particularly preferably 2 mm to 55 mm.

[0030] In a particular embodiment of the method, the force impulse is dampened upon impact with the specimen. In another embodiment of the method, the impact with the specimen is undamped. In a preferred embodiment of the method, the force impulse is exerted by the impact of a defined mass moving at a defined speed towards the specimen. The method according to the invention can be carried out by means of a device 100, 100, 200 according to Fig. 1 or Fig. 2. The defined speed in method step d) can be adjusted by means of a defined drop height when using a device 100, 200. The defined compression and the defined damping can be adjusted using means for adjusting the defined damping upon impact 110, 210.

[0031] The defined bone fracture can be selected, for example, from shaft fracture of the phalanges, shaft fracture of the metacarpals, radius fracture, distal radius fracture, distal radius fracture extension, distal radius fracture flexion, distal radius fracture die-punch fracture, distal radius fracture chauffeur fracture, scaphoid fracture, radial head fracture, coronoid fracture, terrible triad, olecranon fracture, Monteggia fracture, Monteggia like lesion, Galeazzi fracture, capitulum fracture, humerus fracture, distal humerus fracture, proximal humerus fracture, clavicular shaft fracture, lateral clavicle fracture, medial clavicle fracture, femur fracture, distal femur fracture, proximal femur fracture, tibial head fracture, proximal tibial head fracture, distal tibial head fracture, talus fracture, pillon fracture, calcaneus fracture, malleolus fracture, navicular fracture, Patella fracture, metatarsal fracture, scapula fracture, arm fracture, hand fracture, ankle fracture, vertebral fracture, rib fracture, sacrum fracture,Foot fracture, metatarsal fracture, hip fracture, dislocation fracture.

[0032] The specimen may be a human or animal specimen. The specimen may be a formalin-fixed specimen, a Thiel-fixed specimen, or a thawed specimen.

[0033] The defined mass has a weight of at least 1 kg, preferably a weight of at most 72 kg, particularly preferably a weight of 5 kg to 33 kg or 4 to 40 kg. The defined mass is positioned in the axial direction, preferably in the vertical direction, with respect to the specimen. The defined mass can be adjusted, for example, by a mass 112 and one or more additional weights 113.

[0034] The defined velocity of the defined mass upon impact with the specimen is at least 0.5 m / s, preferably at least 3 m / s to 10 m / s, particularly preferably 5 m / s to 6 m / s. The defined drop height is, for example, 10 cm to 150 cm, preferably 20 cm to 120 cm.

[0035] The defined bone fracture can be generated in the specimen 106 by the method according to the invention through a force impulse resulting from a kinetic energy of 5 to 500 joules, preferably 15 to 300 J. The force exerted on the specimen upon impact of the defined mass is preferably at least 50 N, preferably a maximum of 34 kN. The generated kinetic energies are, for example, 15-450 J, preferably 120 to 250 J (see Table 2).

[0036] The defined damping with which the defined mass is decelerated upon impact with the specimen can be adjusted, for example, using at least one shock absorber, preferably at least one hydraulic shock absorber. The impact can occur undamped (defined damping equal to zero) or a defined damping can be adjusted (defined damping greater than 0). The defined damping, which is adjusted using one or more means for adjusting the defined damping 110, 210, for example shock absorbers, is, for example, a maximum of 50 mm, preferably from 0 mm to 40 mm, particularly preferably from 5 mm to 25 mm or 37 mm.

[0037] Defined bone fractures are bone fractures that occur in real accidents. Defined bone fractures are known to the specialist, for example from the AO classification (Maurice E. Müller: The Comprehensive Classification of Fractures of Long Bones in: ME Müller et al. (ed.): Manual of Internal Fixation. 3rd edition. P. 118 ff. Springer-Verlag, Berlin / Heidelberg / New York / Tokyo 1991, ISBN 3-540-52523-8), Orthopaedics and Trauma Surgery Essentials (Steffen Ruchholtz, Dieter Christian Wirtz), intensive course for further training (2nd, completely revised and expanded edition. 1155 illustrations. Paperback. Thieme Georg Verlag, November 2012 - paperback - 770 pages), Orthopaedics and Trauma Surgery, specialist knowledge according to the new further training regulations ((2011) 2nd edition, Scharf, Hanns-Peter; Rüter, Axel; Pohlemann, Tim; Marzi, Ingo; Kohn, Dieter; Günther, Klaus-Peter).

[0038] The invention encompasses methods for creating single-fragment fractures (only one fracture gap), fragmented fractures (up to three additional fragments), and comminuted fractures (more than three additional fragments). Defined bone fractures include shaft fractures (diaphyseal fractures), near-articular fractures (metaphyseal fractures), and articular fractures (fractures involving the articular surface and dislocation fractures).

[0039] According to the invention, the defined bone fracture is reproducibly created using the method according to the invention. This means that a defined bone fracture is selected and created with a certain probability, i.e., with a certain hit rate, using the method according to the invention. Reproducible means that the defined bone fracture is created with a probability of at least 50%, preferably at least 60%, 70%, 80%, 85%, 90%, 95% or more. The method according to the invention enables, for the first time, the predictable creation of defined bone fractures in specimens (no random product). This enables the ethically acceptable production of human specimens with defined bone fractures for commercial use. Reproducibility also leads to a significant cost reduction in all areas where these specimens are required, as fewer rejects are produced.

[0040] The accompanying soft tissue injuries created with the method according to the invention are characteristic of the respective defined bone fracture and are therefore realistic. Open and closed bone fractures are included. In a preferred embodiment of the method, defined bone fractures with a closed soft tissue envelope are created. The accompanying soft tissue injuries characteristic of the respective defined bone fractures are known to the person skilled in the art, for example from Tscherne H, Oestern HJ: Pathophysiology and classification of soft tissue injuries associated with fractures. In: Fractures with soft tissue injuries. Tscherne H Gotzen L.: Berlin; Springer Verlag (1984), pp. 1-9.

[0041] The invention also relates to the preparations produced by means of the method according to the invention.

[0042] The invention relates to a preparation 106, in particular a human preparation with at least one defined bone fracture and accompanying soft tissue injuries, obtainable by the method according to the invention or produced by the method according to the invention. Preparations with defined bone fractures and accompanying soft tissue injuries have not yet been able to be artificially produced. These injuries have so far only occurred in real accidents involving living people. Corresponding preparations can be produced for the first time using the method according to the invention.

[0043] The invention relates to a preparation 106, in particular a human preparation, with at least one defined bone fracture with accompanying soft tissue injuries. The preparation 106 according to the invention preferably comprises a bone fracture with accompanying soft tissue injuries selected from a pilon fracture.

[0044] For the purposes of this study, the soft tissue envelope refers to all of the body's own tissue surrounding the bone in a specimen. The biological tissue surrounding the bone is more elastic and deformable (softer) than the bone itself. The term "soft tissue envelope" includes, among other things, the following main groups: muscles, ligaments, tendons, joint capsules, nerves, skin, and blood vessels. Other components include fascia, connective tissue, periosteum, and bursae. These biological structures have different functions and morphologies and therefore exhibit different mechanical properties. Due to these different properties, these structures react differently to injury mechanisms. In real accidents, therefore, different types of damage occur in different tissues. This tissue-specific damage in a bone fracture is therefore also referred to as "typical" or "accompanying soft tissue injuries."

[0045] Preferably, the preparation 106 is characterized in that the soft tissue envelope is closed. Alternatively, the preparation 106 is characterized in that the soft tissue envelope is open. Using the method according to the invention, preparations with defined bone fractures can be created in which the soft tissues exhibit injuries. Furthermore, preparations with defined bone fractures can be created in which the soft tissue envelope is open. These are openings that can occur when pointed or sharp-edged bone fragments pierce the soft tissues and ultimately the skin. It is clearly recognizable that the openings in the skin and the penetration of the soft tissues occur from the inside out. This is clearly evident from the shapes and form of the openings, as well as the underlying damaged tissue.These bone fractures can therefore be clearly distinguished from those in which the damage to the soft tissue occurs from the outside to the inside.

[0046] Particular embodiments of the invention relate to preparations and processes for their preparation in detail.

[0047] A method characterized in that the defined bone fracture is a pilon fracture, and the defined compression of the specimen 106 is set to 30 to 51 mm and the defined damping to 0 to 25 mm. A specimen comprising a pilon fracture with accompanying soft tissue injuries, obtainable by the method according to the invention.

[0048] During the procedure, the specimen is cast, clamped, or clamped for fixation at one or more locations, preferably at the proximal and distal ends. Before fixation, the specimen can be aligned in a defined geometry.

[0049] In a preferred embodiment, the method for producing at least one defined bone fracture with accompanying soft tissue injuries in a specimen 106 is carried out using a device 100, 200. The device 100, 200 comprises i. at least one guide column 118, 218, ii. at one end of the guide column 118, 218 a base plate 101, 201, iii. a crossbeam 109, 209 with stamp 111, 211, iv. if necessary, at least one means for adjusting the damping upon impact of the defined mass 110, 210, v. at least one clamping plate for fixing the specimen 107, 207, vi. a mass 112, 212 and, if necessary, additional weight 113, 213 for setting a defined mass, vii. at least one further cross member 115, 215 with at least one releasable holding mechanism 114, 214 for positioning the defined mass.

[0050] The traverse 109, 209, 409 can be height adjustable or non-height adjustable.

[0051] The device 100, 500, 600 may comprise testing means, for example, one or more cameras 528 and / or one or more force sensors 103, 503, in order to continuously improve the reproducibility (the probability) that a defined bone fracture is generated and / or to better understand the sequences of the various events during loading. A device 100, 500, 600 comprising testing means can be used to determine one or more parameters selected from the parameters: determining the defined mass, the defined direction, the defined speed of the defined mass, the defined geometry of the specimen 106, the defined compression of the specimen 106, and the defined damping upon impact of the defined mass.The procedure for determining defined parameters is described below and can be used by a person skilled in the art to determine the defined parameters for generating further defined bone fractures in specimens in an analogous manner.

[0052] In a particular embodiment, the device 200 is disassemblable and thus more easily transportable. This allows, for example, specimens to be prepared on-site immediately before their respective use. This is desirable because specimens with defined bone fractures and accompanying soft tissue injuries require special storage conditions, which can be avoided by preparing them immediately before use. Device 200 for carrying out the method according to the invention, disassemblable into a drive module 229, 329 and a mounting module 230, 430 for transporting the device.

[0053] The subject of the application is a drive module 329, 229 for a device 200 for the reproducible generation of at least one defined bone fracture with accompanying soft tissue injuries in a preparation 106 comprising or consisting of i. at least one guide column 218, 318, ii. a mass 212, 312 and, if necessary, additional weight 213, 313 to set a defined mass, iii. at least one crossbeam 215, 315 with at least one releasable holding mechanism 214, 314 for positioning the defined mass, iv. optionally a covering 227, 327, characterized in that the drive module does not comprise any means for fixing the preparation 106.

[0054] The subject of the application is a construction module 430, 230 for a device 200 for the reproducible generation of at least one defined bone fracture with accompanying soft tissue injuries in a preparation 106, characterized in that the construction module 430, 230 does not comprise a defined mass. Construction module 430, 230 for a device 200 for the reproducible generation of at least one defined bone fracture with accompanying soft tissue injuries in a preparation 106 comprising or consisting of i. At least one support column 219, 419, ii. at one end of the support column a base plate 1201, 401, iii. Means for fixing the preparation 402, iv. at least one crossbeam 409, 209 with stamp 211, 411, v. optionally at least one means for adjusting the defined damping 210 upon impact of the defined mass and vi. at least one clamping plate 202, 402 for fixing the specimen 106, vii. optionally a covering 227, 427, characterized in that the superstructure module 430, 230 does not comprise a defined mass.

[0055] The device 100, 200 should always be specially secured to prevent injuries to persons using the device 100, 200 for the method. Such special security includes, for example, specially secured holding mechanisms for the defined mass and a cover 227. The device 100, 200, 500 or drive module 329, 229 comprises at least a doubly secured holding mechanism 214, 314 for positioning the defined mass. The device 100, 200, drive module 329, 229 and / or assembly module 430, 230 comprises at least one cover 227, 327, 427.

[0056] The subject matter of the application is the use of the device 100, 200, 300, 400, 500, 600 for determining one or more parameters selected from the parameters determining the defined mass, the defined direction, the defined speed of the defined mass, the defined geometry of the specimen 106, the defined compression of the specimen 106, the defined damping upon impact of the defined mass. The subject matter of the application is the use of the device 100, 200, 300, 400, 500, 600 for carrying out the methods according to the invention. The subject matter of the application is the use of the device 100, 200, 300, 400, 500, 600 for producing a defined bone fracture with accompanying soft tissue injuries in a specimen 106, 506, preferably for reproducibly producing the defined bone fracture with a probability of at least 50%.

[0057] According to the invention, the preparation 106 is a dead human body or dead animal body or a part of a dead human body, for example a severed body part (e.g. arm, foot, knee) or a part of a dead animal body. The preparation 106 can be frozen. The thawing process is initiated 15 to 24 hours before the procedure for creating the bone fracture, depending on the objective and anatomical region. For this purpose, the preparation 106 is taken out of the refrigerator (at minus 20 degrees Celsius), the packaging material is removed and stored at room temperature (20 to 22 degrees Celsius). Processing is possible at temperatures from 10 degrees Celsius to 25 degrees Celsius, preferably 15 degrees Celsius to 23 degrees Celsius. A formalin- or Thiel-fixed preparation 106 can be processed directly without major preparation.The donors of the preparations are generally between 78 and 86 years old, but the donors can also be older or younger at the time of donation of the preparations. In a particular embodiment of the method, the preparation 106 originates from a donor with an age of more than 60 years, 70 to 90 years, preferably 78 to 86 years. In a particular embodiment of the invention, the preparation 106 according to the invention, which comprises the defined bone fracture with accompanying soft tissue injuries, is more than 60 years old, preferably 70 to 90 years, particularly preferably 78 to 86 years old.

[0058] The preparation 106 can be a whole body preparation or a body part or a defined anatomical region. The preparation 106 can comprise at least one anatomical region selected from the anatomical regions hand and 1 to 5 fingers, wrist, elbow, shoulder, knee, ankle, foot and 1 to 5 toes, hip, pelvis, spine, thorax, ribs. The preparation 106 can comprise at least one joint affected by the force application, preferably 1 to 3 joints affected by the force application. The joint or the joints can have a joint position in the defined geometry, selected from neutral position, flexed or extended, rotated, varus or valgus position.

[0059] The force is preferably not introduced into the specimen directly, but indirectly, for example via a punch 111, 211, 511 by means of a device 100, 200, 500. The indirect force introduction enables precise fixation of the specimen 106, 506. The interface between the device 100, 500 and the specimen 106, 506 should create a flush force connection, for example by pouring the ends of the specimen 106, 506 with a cold-curing polymer such as epoxy resin in a mold 105, 505 and screwing the mold 105, 505 to the device 100, 500.

[0060] The specimen 106 can be clamped proximally and / or distally for fixation in a defined geometry. The specimen can be rotated by a defined angle around at least one of the clamps and fixed in this defined geometry. The defined geometry of the specimen 106 with respect to the defined force impulse when performing the method corresponds to the joint position and joint angles of a person or animal with respect to the force impulse acting in a real accident. The defined geometry of the specimen 106 can be easily determined, for example, by analyzing the course of the accident, for example through documents, images, video recordings and / or eyewitness reports. One or more adapters can be used to fix the specimen 106 in the defined geometry when performing the method for creating a defined bone fracture with accompanying soft tissue injuries.

[0061] In one embodiment of the method, before the fixation of the preparation 106, a piece of bone is freely prepared at the proximal and distal end of the preparation 106 and cast in a defined geometry with a hardening material into a mold 105, 505 and then fixed at the proximal and distal end in a device 100, 500 with a clamping plate 107, 507 and / or at least one means for fixing the preparation 102, 502. In another embodiment of the method, before the fixation of the preparation 106, a piece of bone is freely prepared at the proximal or distal end of the preparation 106 and cast in a defined geometry with a hardening material into a mold 105, 505 and then fixed at the proximal or distal end in a device 100, 500 with a clamping plate 107, 507 or at least one means for fixing the preparation 102, 502.

[0062] According to the invention, the fixation of the preparation 106 is also referred to as clamping of the preparation 106.

[0063] Each person, e.g., the injured person, and each specimen 106 has three axes of movement (sagittal, transverse, and longitudinal axes), which in turn span the three body planes (sagittal, transverse, and frontal planes) (internal coordinate system). The same applies to space (external coordinate system), e.g., the device 100. When the specimen 106 is fixed in a defined geometry, the internal coordinate system of the specimen, which is predetermined by the desired joint position of the specimen 106 in the event of an accident, is synchronized with the external coordinate system, which is predetermined by the device 100, 200, or 500. When using a device 100, 200, or 500, the external coordinate system is not variable, but is fixed by the device 100, 200, or 500.The internal coordinate system of the specimen 106 is flexible and is adapted to the external coordinate system of the device 100, 200, 500 such that, when the method according to the invention is carried out, the joint position and, if applicable, the joint angles in the specimen 106 are reproduced, which would produce the defined bone fracture in an accident under real conditions. Thus, the method according to the invention simulates the realistic generation of the defined bone fracture in a specimen 106, 506. Therefore, the method according to the invention does not produce random products, but rather specifically preselected, defined bone fractures with the real accompanying soft tissue injuries.

[0064] Fixing the specimen 106 in the defined geometry represents the joint position of the real accident sequence with respect to the acting force direction. The selected clamping of the specimen 106 in the device 100, 200 during the implementation of the method results from the theoretical preliminary work in steps 1 and 2 (see the following description) when determining the parameters for a new defined bone fracture. Since the method according to the invention is supposed to simulate a real trauma or accident, the specimen 106 is clamped in the device 100, 200 in a defined geometry that results from accident analyses. The angle settings of the joints can be made, for example, by means of a goniometer.Since the impulse is transmitted in the device 100, 200 by the impact punch 111, 211, the desired geometry of the joint(s) in the specimen 106 must be capable of being mapped in relation to the impact punch 111, 211. This means that a specimen 106 is fixed in a defined geometry relative to the impact punch 111, 211 of the device 100, 200. The mechanism of action of a device 100, 200 for producing the defined bone fracture in the specimen 106 is always the same. For example, by means of a gravitationally accelerated, defined mass that impacts the specimen 106 from a vertical direction with a defined kinetic energy, resulting in a defined force impact on the specimen 106.

[0065] To align the preparation 106 in the defined geometry, for example, adapters and molds 105 such as pouring devices, foam mats, bandages, tension straps, cold-curing polymers, clamps, angle pieces and other aids are used. Thereby, the clamping possibilities for the preparation 106 in the device 100, 200 are very variable and any conceivable defined bone fracture can be produced in this way.

[0066] Foam mats or other aids with similar properties can be used to protect the skin of the fractured preparation 106. Foam mats protect the biological structures in the preparation 106, for example the wrist area, by passively increasing the area of force transmission. This prevents the preparation 106 from fracturing below the targeted position.

[0067] To align and fix (clamp) the specimen 106, one or more adapters can be used to support the alignment and fixation in the defined geometry. The geometry of the adapters is determined by a specialist based on the joint position and joint angles in the underlying real-life accident scenario.

[0068] For example, groups of accident scenarios can be combined, and technical adaptations can be made or adapters developed for the underlying mechanism of action of this group to enable optimal clamping of the specimens in the device 100, 200. For example, the adapter 04 can be used to create different classes of distal radius fractures. The design of the respective adapter depends on the orientation of the anatomical structures of the bones in the specimen 106 during a real accident, the movement of the anatomical region containing the bone in question during the accident, and the mode of action of the device 100, 200.

[0069] The following adapters can be used to clamp or fix a specimen 106 in the defined geometry:

[0070] Adapter 01 has the shape of a bowl and can be fixed at various points in the device 100, 200 in order to align a specimen 106 in the defined geometry. Adapter 02 (hemisphere) has a spherical surface. Adapter 02 can be supported on the base plate 101, 201 of the device 100, 200. On the round surface of adapter 02, for example, a hand can be moved from the neutral position. Adapter 03 has the shape of a truncated cone. It can be supported on the base plate 101, 201 of the device 100, 200. On the inclined surface of adapter 03, the hand can be moved laterally until it exhibits radial abduction from the neutral position.

[0071] Adapter 04 is modeled after a handlebar or bicycle handlebar. Adapter 04 can be supported on the base plate 101, 201 of the device 100, 200.

[0072] Adapter 05 has an inclined surface with an angle of 15 degrees and can be fixed at various locations in the device 100, 200 in order to align a preparation 106 in the defined geometry.

[0073] Adapters 06 and 07 have the shape of a pin, with one end of the pin being rounded and the adapter 06 having a surface of approx. 3 cm 2 and the adapter 07 an area of ​​5 cm 2 The pin is positioned vertically, with the rounded side facing the specimen 106 under the impact punch 111, 211. The end of the adapter 06 or 07 is placed centrally over the desired fracture site. Foam mats can be applied between the surface of the adapter and the specimen 106. The foam mats can have different degrees of hardness and, on the one hand, prevent the adapter 06 or 07 from slipping off the targeted fracture site, and, on the other hand, they passively increase the area of ​​force transmission.

[0074] Adapter 08 has an inclined surface with an angle of 30 degrees and can be fixed at various locations in the device 100, 200 in order to align a specimen 106 in the defined geometry.

[0075] Adapter 09 has an inclined surface with an angle of 45 degrees and can be fixed at various locations in the device 100, 200 in order to align a preparation 106 in the defined geometry.

[0076] Adapter 10 has an inclined surface with an angle of 60 degrees and can be fixed at various locations in the device 100, 200 in order to align a specimen 106 in the defined geometry.

[0077] Adapter 11 (double finger table) and adapter 12 (triple finger table) are used to clamp fingers. In a vertical position, the wrist is held in the neutral position and the phalanges of the respective finger joints are inserted into adapter 11 or 12. The weight of the impact stamp 111, 211 holds the specimen 106 in the desired, defined geometry in this clamping position. Adapter 11 or 12 is supported flatly on the base plate 101, 201 of the device 100, 200 and can be moved on the base plate 101, 201. With the finger joints inserted, the hand cannot be moved laterally from the neutral position, or only if it does not stand rigidly under the weight of the impact stamp 111, 211, but rather evades.

[0078] Adapter 13 is a humeral box for embedding the humerus and can be fixed at various locations in the device 100, 200 in order to align a preparation 106 in the defined geometry.

[0079] Adapter 14 is a height-adjustable clavicle frame for securing the clavicle and can be fixed at various locations in the device 100, 200 to align a specimen 106 in the defined geometry. The medial end of the clavicle can be fixed in a clamping ring on the adapter 14.

[0080] Adapter 15 is an angle plate with which an angle of 90 to 130 degrees can be specified in the preparation 106.

[0081] Adapter 16 (sandbox) is a mold that can be filled with sand and on which the specimen 106 can be supported. Foam mats can be applied to the bottom of the adapter 16 under the supported specimen 106. The adapter 16 can be filled with quartz sand and screwed onto the base plate 101, 201 of the device 100, 200. The fill volume of the adapter 16 can vary depending on the defined bone fracture and the specimen 106 used.

[0082] Adapter 17 (knee flexion chamber) is based on the model of an inverted vise. This means that adapter 17 applies a parallel clamping force from two sides to the selected specimen 106. This securely fixes the specimen 106. Adapter 17 can be screwed to the impact punch 111, 211. The force generated when the defined mass impacts the impact punch 111, 211 is thus directly transmitted to the specimen 106. Adapter 17 features a shaft joint, which allows the surface pressing on the specimen 106 to be adjusted. This allows the force application point to be precisely targeted for the defined bone fracture in the joint.

[0083] Adapter 18 (Monteggia clamp) is used for clamping, for example, the forearm. The adapter can be fixed to the base plate 101, 201, or to a location on the specimen 106.

[0084] In an analogous manner, additional adapters can be developed if the defined geometry of the preparation 106 and / or the device 100, 200 so requires. Suitable adapters and other aids are known to the person skilled in the art.

[0085] In one embodiment of the method, the specimen 106 or a specific anatomical structure in the specimen 106 is fixed centrally below the force application point, for example, the impact punch 111, 211. This ensures that the kinetic energy results in the force impulse at the correct location on the specimen and leads to the defined bone fracture and the accompanying soft tissue injuries. In another embodiment of the method, the specimen 106 is fixed decentrally below the force application point, for example, the impact punch 111, 211, to create the defined bone fracture. The clamping of the specimen 106 can vary depending on the defined bone fracture and the anatomical region of the specimen 106. The specimen 106 is fixed in such a way that it remains fixed during the force impulse. The specimen 106 can move during the force impulse, but should preferably not evade or slip.For this reason, in a preferred embodiment of the invention, at least one bone end on the specimen 106 is freed and fixed in a mold 105, for example, with a casting resin. In another embodiment of the invention, both ends of the specimen 106 are fixed, for example, cast, in a mold 105 for fixation. The mold or molds 105 are fixed in the device 100, 200, for example, by means for fixing the specimen 102, e.g., an adjustable slide or a clamping plate 107. If one end of the specimen 106 is not cast, it is preferably "clamped." The following two possibilities exist, among others: a) the end is clamped between at least two metal jaws - like a vice, e.g.with adapter 17 or b) the end is placed vertically or at a 90 degree angle below the force application point, for example the impact punch 111, 211, so that the preparation 106 is held in position by its own weight and by the weight of the impact punch 111, 211.

[0086] In the methods described below for creating defined bone fractures in specimens 106, 506, a device 100, 200, 300 is used together with 400, 500. A gravitationally accelerated mass is used as the defined mass, which exerts a force impact on the specimens in the vertical direction. The defined speed is therefore set in the device 100, 200, 400, 500 by means of a height from which the defined mass falls onto the specimen 106. The defined compression and the defined damping are set by the means for adjusting the damping upon impact 110, 210, 510. For this purpose, shock absorbers are preferably used in the device 100, 200, 300, 400, 500. When using shock absorbers, the adjustment is then carried out over a distance (travel path). The defined damping is then also set as a distance by the damped part of the compression.

[0087] Method for producing at least one defined bone fracture with accompanying soft tissue injuries in a preparation 106 using a device 100, 200 comprising the steps a) Selection of a defined bone fracture; b) Selection of a preparation 106; c) setting a defined mass and positioning the defined mass in a defined direction with respect to the preparation 106 by means of a holding mechanism 114, 214; d) aligning the preparation 106 in a defined geometry with respect to the direction from which the defined mass impacts the preparation 106 when the holding mechanism 114, 214 is released by means of means for fixing the preparation 101, 102; e) setting a defined speed at which the defined mass impacts the preparation 106 when the holding mechanism 114, 214 is released; f) setting a defined compression to which the preparation 106 is subjected upon impact of the defined mass when the holding mechanism 114, 214 is released; g) setting a defined damping with which the defined mass is decelerated upon impact with the preparation 106 when the holding mechanism 114, 214 is released; h) triggering the holding mechanism 114, 214 to accelerate the defined mass in a defined direction towards the preparation 106; i) removing the means for fixing the preparation 102;wherein steps b) to g) can be carried out in a variable order.

[0088] The following examples illustrate the procedure and the preparations 106.

[0089] Method for producing a distal radius fracture of classification 23 A2, 23 C1 - C3 (dorsal) according to AO in a specimen 106 with a device 100, 200, characterized in that a) a distal radius fracture of classification 23 A2, 23 C1 - C3 (dorsal) according to AO is selected, b) a specimen 106 comprising or consisting of a hand, forearm, and upper arm is selected, c) a defined mass of 16.8 to 19.3 kg is set, d) the specimen 106 is aligned in a defined geometry with respect to the direction from which the defined mass impacts the specimen 106 when the holding mechanism 114, 214 is triggered, with the aid of means for fixing the specimen 106, for example as described in Example 3, e) the defined speed is set to 76 to 102 cm by means of the drop height f) the defined compression is set to 22 to 30 mm,g) the defined damping is set as a damped portion of the defined compression to 6 to 14 mm, h) the holding mechanism 114, 214 is triggered, i) the specimen 106 is removed from the device 100, 200. The subject matter of the invention is a specimen 106 comprising a distal radius fracture of the classification 23 A2, 23 C1 - C3 (dorsal) according to AO, obtainable by the above method for producing a distal radius fracture of the classification 23 A2, 23 C1 - C3 (dorsal) according to AO in a specimen 106.

[0090] Method for producing a pilon fracture (for example 43 B3 - B4, C1 - C3 according to AO) in a specimen 106 with a device 100, 200, characterized in that a) a pilon fracture (for example 43 B3 - B4, C1 - C3 according to AO) is selected, b) a specimen 106 comprising or consisting of foot and lower leg is selected, c) a defined mass of 24.7 to 38.5 kg is set, d) the specimen 106 is aligned in a defined geometry with respect to the direction from which the defined mass impacts the specimen 106 when the holding mechanism 114, 214 is triggered, with the aid of means for fixing the specimen 102, for example as described in Example 23, e) the defined speed is set to 100 to 111 cm by means of a drop height, f) the defined compression to 30 to 51 mm, g) the defined damping is set as the damped part of the defined compression to 0 to 25 mm,h) the holding mechanism 114, 214 is triggered, i) the preparation 106 is removed from the device 100, 200. The subject matter of the invention is a preparation 106 comprising a pilon fracture (for example, 43 B3-B4, C1-C3 according to AO) obtainable by the above method for producing a pilon fracture (for example, 43 B3-B4, C1-C3 according to AO) in a preparation 106.

[0091] Further bone fractures can be created in an analogous manner.

[0092] When generating defined fractures using the method according to the invention, the individuality of the specimens (anatomical, geometric, biomechanical) can influence the defined parameters such as the defined mass, the defined velocity, the defined compression, the defined damping, and the defined geometry. For this reason, a range / value range is specified for these parameters. With the described options for clamping or fixing the specimen in the device 100, 200 and the setting of the technical parameters in the device 100, 200, overlaps arise for related fractures, e.g. distal radius fracture extension and distal radius fracture flexion. This means that, for example, for a distal radius fracture of classification 23 A2 (dorsal) according to AO, the same clamping is required as for a distal radius fracture of classification 23 C1 - C3 (dorsal) according to AO.Since the various defined bone fractures sometimes differ only minimally with regard to the fracture progression or the force applied in a real accident, the settings on the device 100, 200 for generating the defined bone fractures also differ barely. In these cases, the individuality of the individual specimen 106, which is recognizable by a specialist, must be taken into account when setting the defined parameters and fixing or clamping the specimen 106.

[0093] The procedure for adapting the method according to the invention to generate a newly selected, defined bone fracture with accompanying soft tissue injuries is described below. Since it is virtually impossible to recreate an accident (e.g., a motorcycle accident) in reality and, as in reality, to use a complete human body as the specimen 106 for this purpose, the replication of reality using the method according to the invention must apply the necessary forces and velocities to a specimen 106, for example, using the device 100, 200. The device 100, 200 always operates according to the same principle. However, the injuries and accidents underlying the defined bone fractures always differ.For each new bone fracture, the specimen 106 is fixed in the device 100, 200 in the defined geometry with respect to the direction from which the defined mass impacts the specimen 106 when the holding mechanism 114, 214 is triggered, optionally using adapters that support the fixation in the defined geometry.

[0094] The defined compression of the specimens 106 depends on the anatomical region and the selected bone fracture. The defined compression can be determined by a specialist depending on the selected defined bone fracture and the specimen 106. The defined damping depends on the anatomical region of the specimen 106 and the selected defined bone fracture. The defined damping can be determined by a specialist depending on the selected defined bone fracture and the specimen 106. The defined compression and damping prevent the specimen 106 from being excessively stressed and the anatomical structures (e.g., bones and soft tissue) in the specimen 106 from being destroyed in an unrealistic manner. The defined speed of the defined mass is the speed that the defined mass has at the time of the force impact, i.e.the time of impact of the defined mass on the specimen 106 or, when using a device 100, 200, upon impact with the impact punch 111, 211. This depends on the selected defined bone fracture and the forces acting during the underlying accident. The defined speed can be determined by a specialist depending on the selected defined bone fracture, the defined mass, and the specimen 106.

[0095] In order to optimally adapt the clamping of the specimens and the settings on the device 100, 200 to the conditions of the respective specimen 106, individual specimens can be examined before carrying out the method for creating a defined bone fracture in the specimen 106, for example by taking and examining X-rays and CT images, or by performing mechanical and / or orthopedic function tests (e.g., manually) on the joint(s). This makes it possible to take into account deficiencies or anatomical peculiarities in individual specimens, such as the weight of the specimen 106, the fat content of the soft tissue mass, the length, width, and diameter of the bones in question, the joint spacing, the maximum joint angles, bone quality, and degenerative diseases. Degenerative diseases include, among others, the formation of osteophytes, joint instabilities, osteoarthritis, and, above all, osteoporosis.If a specimen 106 is affected by such restrictions, bone fractures can only be created to a limited extent or not at all. For example, bone density measurements can be performed on the specimens. Accordingly, to create a defined bone fracture in an "old" specimen 106 (e.g., 90 years old, female, slight osteoporosis, slight restriction of joint mobility), a slightly different setting of the defined parameters and the defined geometry and clamping on the device 100, 200 are set than for a "young" specimen 106 (e.g., 60 years old, male, no further restrictions). The methods and procedures for determining the quality of a specimen 106 are known to the person skilled in the art. In particular, the quality of specimens can be assessed by a person skilled in the art, even without precise measurements, based on age, stature, dietary habits, gender, and the like, and taken into account accordingly.

[0096] The determination of the defined parameters for a newly selected bone fracture with accompanying soft tissue injuries comprises several steps i.) to xi.), which can be performed sequentially or concurrently and in a variable order (steps iii.) to xi.)).

[0097] The determination of the defined parameters includes the steps i. Selection of a new defined bone fracture; ii. Evaluation of at least one eyewitness report, patient report, image, video or document on the origin of the defined bone fracture in at least one casualty; iii. Based on i.) and ii.) determination of the speed, direction of movement and joint position in the anatomical region in relation to the direction of force acting during the occurrence of the defined bone fracture; iv. Theoretical assumption of the mass of the casualty and calculation of the inertia and direction of movement of the casualty; v. Assignment of the injury to a fracture class, for example according to the AO Trauma Register; vi. Development of at least one theory for the reproducible generation of the defined bone fracture in a specimen 106; vii. Calculating the energy range for producing the defined bone fracture in a specimen 106 and determining the defined mass and the defined velocity of the defined mass, viii. Selection of a defined anatomical region for the specimen 106, ix. Determining the axial symmetry of the specimen 106 with respect to the force vector acting upon impact of the defined mass and establishing the defined geometry for the fixation of the specimen 106 with respect to the axially, preferably vertically guided mass, for example by adapting the inner coordinate system of the specimen 106 to the outer coordinate system of a device 100, 200 for simulating a real accident. x. Calculation of the defined compression to which specimen 106 may be subjected upon impact of the defined mass, xi. Calculation of the defined damping upon impact of the defined mass on specimen 106, whereby the order of the steps is variable.

[0098] The adaptation of the method according to the invention for the reproducible creation of a new defined bone fracture with accompanying soft tissue injuries is a three-step process:

[0099] In the first stage, a defined bone fracture is selected from the common fracture classifications (e.g., AO), which is to be created in specimens. The injury process underlying the defined bone fracture is analyzed and the physical and biomechanical parameters are determined (e.g., research, databases, German Trauma Register). The analysis of the development of the bone fracture in real injury processes is carried out, for example, through eyewitness and / or patient reports, the evaluation of images and / or videos. The physical parameters that are determined are the speeds, e.g., the speed with which a body or a person, preferably the injured person, moves, the direction of movement of individual body segments (e.g.,a foot, a lower leg) the mass of such a segment, a body or a person, in particular the mass of the injured person and the resulting energy during the accident. The biomechanical parameters that are determined are the behavior of the biological material in the accident underlying the bone fracture, such as the joint angles of the affected anatomical region (e.g. the upper extremity), the mass inertia of the moving body (usually the body of the injured person), the direction of movement of the body during the accident and the fracture classifications. The joint positions in accidents can be determined, for example, through the analysis of video recordings, literature research, biomechanical studies on sports technology and sports injuries or ergonomics studies.

[0100] In the second stage, a theory of the injury mechanism is developed. This theory is verified using biomechanical calculations and model simulations, for example, kinematic model calculations to determine velocities, accelerations, positions, and joint angles, inverse dynamic calculations of the acting forces and reaction forces, as well as the moments acting on the osseous and ligamentous structures of the specimens. The calculated defined parameters, namely the calculated defined mass, the calculated defined direction, the calculated defined velocity of the calculated defined mass upon impact, the calculated defined geometry of the specimen 106 in relation to the calculated force impulse upon impact, the calculated defined compression of the specimen 106, and the calculated defined damping upon impact are verified using model calculations. Methods of applied biomechanics (e.g.Anthropometry, kinematics, dynamics, kinetics), motion analysis, dynamometry, and kinemetry are applied. These model calculations are familiar to those skilled in the art, for example, from Georg Kassat, Biomechanics for Non-Biomechanics, Fitness-Contur-Verl., Bünde 1993; David A. Winter, Biomechanics and Motor Control of Human Movement, 4th ed. Wiley, J, New York, NY 2009; Benno Kummer: Biomechanik. Dt. Ärzte-Verl., Cologne 2004.

[0101] A defined bone fracture can, of course, arise in various ways. According to the invention, the defined bone fracture is preferably created using the method according to the invention, preferably using a device 100, 200. This means that the data and the results of the calculations from stages one and two are translated into the operating principle of the method according to the invention. The method according to the invention is characterized in that a defined bone fracture can be created with little stress on the specimen 106 and with little equipment expenditure. This makes it possible to create the defined bone fracture more quickly and with a high degree of probability. In a preferred embodiment, the theoretical calculation therefore comprises the transfer of the calculated parameters to the creation of the defined bone fracture in a specimen 106 using a device 100, 200.In the device 100, 200, the defined bone fracture in the specimen 106 is generated by the force impact of a gravitationally accelerated mass. By specifying the defined direction from which the defined mass impacts the specimen 106, the defined geometry in which the specimen 106 must be aligned in the device 100, 200 is necessarily defined by the biomechanical parameters.

[0102] In the third step, the method according to the invention is carried out on specimens using the calculated, defined parameters. In order to handle the specimens, particularly human specimens that are human body donations, in an economically and ethically responsible manner, high reproducibility is sought in the generation of the defined bone fracture with accompanying soft tissue injuries. Establishing reproducibility involves the defined parameters leading to the generation of the defined bone fracture with accompanying soft tissue injuries, regardless of the respective individual properties of the specimen 106. This means that a defined bone fracture is generated with a probability (hit rate) of at least 50%, preferably at least 60%.Whether the generated bone fractures correspond to the selected defined bone fractures is checked, for example, using X-rays or CT images, which are examined and assessed by experienced trauma surgeons and compared with the common fracture classifications (including AO). If the images and later the bone fractures are classified as consistent, i.e. realistic, the focus is on reproducibility in order to achieve the desired probability (hit rate) of at least 50%, 60%, 70%, 80% or more. A total of 300 simulations are required to reproduce all relevant fractures in an anatomical region (which includes one joint) with a probability (hit rate) of at least 60%. The method according to the invention is preferably carried out on specimens 106, 506 using the devices 100, 200, 500, 600.Depending on the selected defined bone fracture, the biological structures in specimens 106 and 506 are subjected to high-energy impulses and / or shear forces and bending moments. The applied force is measured using dynamometry, and the movements of the individual segments of specimen 106 are recorded on video. The collected data are analyzed and evaluated. This procedure is known, for example, from Dieter Fink (2013) (Master's thesis: Conception and creation of a software package for synchronization, data acquisition, and measurement signal display for the Essex-Lopresti simulator), Marc Ebinger (2013) (Master's thesis "Design and Evaluation of a novel simulator for high-speed injuries of the human forearm"), and Robert Holz (2013) (Master's thesis "The mechanism of the Essex-Lopresti: Investigation of tissue failure using a newly developed simulator").For each defined bone fracture, this procedure determines a unique combination of technical parameters (settings on the device 100, 200) and biomechanical parameters (orientation of the specimen 106 in the defined geometry with respect to the direction from which the defined mass impacts the specimen 106, and fixation of the specimen 106 in this defined geometry). These parameters are explained in the examples for generating various defined bone fractures.

[0103] The generation of a defined bone fracture with accompanying soft tissue injuries according to the method according to the invention, for example when checking the calculated parameters, establishing the method or using it for reproducible generation, comprises the following steps: if necessary, thawing the preparation 106, if necessary, pouring the severed stump, aligning and clamping the preparation 106 in the device 100, 200, setting the defined parameters, triggering the holding mechanism 114, 214, if necessary, checking and documenting the results.

[0104] Table 1: Defined bone fractures with accompanying soft tissue injuries that can be reproducibly produced (i.e. with a probability of at least 50% or more) in human specimens. Anatomical region Example No. fracture status hand / fingers 1 Phalanges Reproducible 86% 2 Metacarpals Reproducible 79% wrist 3 Extension (Smith) Reproducible 90% 4 Inflection (Coles) Reproducible 86% 5 Die-punch Reproducible 69% 6 chauffeur Reproducible 75% 7 Scaphoid Reproducible 60% elbow 8 Radius head Reproducible 79% 9 Coronoid Reproducible 90% 10 Terrible Triad Reproducible 92% 11 Olecranon Reproducible 94% 12 Monteggia Reproducible 60% 13 Monteggia-like lesion Reproducible 66% 14 Galeazzi Reproducible 53% 15 Capitulum Reproducible 72% 16 distal humerus Reproducible 79% shoulder 17 Clavicle shaft Reproducible 70% 18 lateral clavicle Reproducible 52% 19 proximal humerus Reproducible 76% Knee 20 distal femur 21 tibial head Reproducible 72% ankle 22 Talus 23 Pillon Reproducible 62% 24 Calcaneus Reproducible 61%

[0105] Table 2: Examples of defined parameters for generating defined bone fractures (Def. = defined) Nr. Defined bone fracture Classification according to AO Trauma Register Def. Mass in kg Def. fall height in cm Defined compression in mm Defined damping in mm Energy in joules 1 Shaft fractures of the phalanges - V 78 A2, B2, C2 5.2 to 9.8 29 to 46 2 to 8 0 to 5 15 to 44 2 Shaft Fractures of Metacarpals I - V 77 A2, B2, C2 7 to 11.2 35 to 52 6 to 14 0 to 9 24 to 57 3 distal Radius Fracture Extension 23 A2, 23 C1 - C3 (dorsal) 16.8 to 19.3 76 to 102 22 to 30 6 to 14 125 to193 4 distal Radius Fracture Flexion 23 A2, (palmar) 16.8 to 20.5 82 to 105 25 to 35 5 to 17 135 to 211 5 distal Radius fracture / Die-punch fracture 23 C1 - C2 17 to 23.1 90 to110 22 to 31 9 to 15 150 to 249 6 distal Radius fracture / Driver fracture 23 B1 16.6 to 18.3 80 to 93 20 to 28 6 to 14 130 to 167 7 Scaphoid Fracture 72 A2, B2 - B3 16.8 to 19.5 75 to 88 24 to 32 10 to 17 124 to 168 8 Radioscope fracture 21 B2 (Type I - III after Mason) 18.3 to 21.5 75 to 88 21 to 29 9 to 15 135 to 168 9 Coronoid Fracture 21 B1 (Regan & Morrey Type I - III 18.2 to 22.8 75 to 86 20 to 33 8 to 16 134 to 192 10 Terrible Triad 21 C1 18.9 to 26.8 85 to 100 24 to 38 10 to 18 158 to 289 11 Olecranonfracture 21 B1, C1 17.1 to 20 61 to 79 4 to 17 0 to 9 116 to 139 12 Assembly fractures 21 A1, B1 16.8 to 17.9 72 to 88 28 to 46 10 to 17 119 to 155 13 Monteggia-like lesion 21 B3 16.8 to 18.4 75 to 92 30 to 46 9 to 21 124 to 166 14 Galeazzi fracture 22 A3, B3, C1 - C3 18.5 to 22.6 95 to 107 24 to 39 6 to 17 172 to 237 15 Capitulum fracture 13 B3 20.5 to 24.2 70 to 81 14 to 22 6 to 13 141 to 192 16 distal humerus fracture 13 B1, B2, C1 - C3 20.2 to 27.2 68 to 81 26 to 37 0 to 15 135 to 216 Nr. Defined bone fracture Classification according to AO Trauma Register Def. Mass in kg Def. fall height in cm Defined compression in mm Defined damping Energy in joules 17 clavicular shaft fracture Type A and B 12.3 to 16.5 55 to 68 4 to 12 0 to 06 66 to 110 18 I lateral clavicle fracture Type I and II according to Neer 10.3 to 21.9 57 to 76 5 to 14 0 to 7 58 to 163 19 proximal humerus fracture 11 B1, B3, C1 - C3 19.2 to 28.8 65 to 88 29 to 44 0 to 16 122 to 249 20 distal femur fracture 33 C1 - C3 26.0 to 38.7 99 to 116 31 to 49 0 to 37 253 to 440 21 Tibial head fracture 41 B1 26 to 31 96 to 112 35 to 47 10 to 13 245 to 341 22 Talus fracture Type II, Type III according to Hawkins 24.8 to 37.2 68 to 83 26 to 48 0 to 22 165 to 303 23 Pillon fracture 43 B3 - B4, C1 - C3 24.7 to 38.5 100 to 111 30 to 51 0 to 25 242 to 419 24 Calcaneus fracture Type 2A, 2C, Type 3AB, 3AC according to Sanders 24.1 to 32.7 90 to 98 25 to 43 0 to 18 213 to 314 25 Distal radius fracture 23 B3 20 to 23 76 to 102 25 to 36 10 to 16 149 to 230

[0106] The defined damping can be zero, meaning the impact is undamped. When creating a capitulum fracture, Galeazzi fracture, or Monteggia fracture in specimens, the defined damping cannot be set to zero, as this would result in uncontrolled damage to the biological structures.

[0107] The invention also relates to the use of preparations according to the invention or the method according to the invention for the training or further education of medical personnel, clinics and doctors, in particular in the fields of orthopaedics and trauma surgery, in particular surgeons.

[0108] A further area of ​​application for preparations according to the invention or the method according to the invention or the commercial device 200 is the manufacturers of articles and devices for trauma surgery and orthopedics. This industry includes all manufacturers of implants for joint replacement (e.g., artificial hip or knee joints) and for fracture treatment (osteosynthesis).

[0109] Further applications of the preparations according to the invention or the method according to the invention or the commercial device 200 are in the consumer goods industry (e.g. automotive industry, sports equipment manufacturers), in accident research and accident analysis, in disaster control, in military training and for the preparation of expert opinions.

[0110] Devices 100, 200, 500, drive module 329, 229 in combination with assembly module 430, 230, which are suitable for carrying out the method according to the invention.

[0111] Simple variants are known in the state of the art, for example from McGinley et al. (2003), Robert Holz (2013) (Master's thesis "The mechanism of the Essex-Lopresti: Investigation of tissue failure using a newly developed simulator"), Marc Ebinger (2013) (Master's thesis "Design and evaluation of a novel simulator for high-speed injuries of the human forearm") and Dieter Fink (2013) (Master's thesis "Conception and creation of a software package for synchronization, data acquisition and measurement signal display for the Essex Lopresti simulator").

[0112] Based on this, two different devices (100, 200, and 500) were developed. A scientific prototype of the device (100, 500) was developed to determine and validate the defined parameters so that the defined bone fracture can be reproducibly created in a specimen (106). This scientific prototype includes implemented measurement technology, software-controlled synchronization of the measurement technology, a solid construction for reliable and valid data acquisition, and a mechanical safety system (electrically supported). At least two people are required to operate the device (100, 500).

[0113] Secondly, a device 200, drive module 329, 229 in combination with add-on module 430, 230 for commercial application, characterized in that the device 100, 200 does not include any measuring technology (for faster, more effective work), has a lighter modular design, is transportable and can be quickly assembled and disassembled, has at least one electrical safety system that is mechanically supported, and only at least 1 person is required for operation.

[0114] In contrast to the device of McGinley et al., the devices 100 and 200 can be variably adjusted and are therefore suitable for producing various defined bone fractures. The device of McGinley et al. had a fixed kinetic energy upon impact of 238 J, neglecting air and sliding friction.

[0115] The device 100, 200 can be adjusted so that the speed upon impact of the defined mass on the specimen 106 is 4.2 m / s or more and the energy upon impact is 240 J or more. The technical parameters that can be adjusted on the device 100, 200 include the defined mass, here the mass of the falling body, which is adjustable from 11.8 to 62.9 kg, the defined speed, here the height of the falling body, adjustable from 0 to 1100 mm, the defined compression, here the path (travel path) that the specimen 106 is allowed to move in the direction of the acting force and the defined damping, here the point in time at which the shock absorbers remove the (residual) energy from the system.

[0116] The mechanical requirements of the device 100, 200. From the parameters of the defined mass, the time required until impact, and the fall height, the energy, the speed, and hence the acceleration can be calculated. Furthermore, the momentum can be calculated, and from this, the kinetic energy and the force can be calculated (theoretically) from the momentum set. The results of such calculations can then be compared with the calculations that were made beforehand for carrying out the method for creating a defined bone fracture with accompanying soft tissue injuries (see Procedure for adapting the inventive method for creating a newly selected defined bone fracture with accompanying soft tissue injuries). They also serve for comparison with the forces and speeds actually measured during the procedure.The fixation and clamping of the specimens can be adjusted to anatomical deviations in the devices 100, 200 and is stable at the same time. Adjustment options are considered that enable the central positioning of the different specimens under the force application point in the devices 100, 200 when performing the method. In addition, in the devices 100, 200, the proximal and distal clamping of the specimen 106 can be rotated separately to impart pronation to the specimen 106. Furthermore, the devices 100, 200 include safety devices that ensure safe operation on and with the devices 100, 200.

[0117] The device 500, 600 can comprise a measuring technology. The deformation of the biological structures and the chronological sequence of the injuries occurring are important for analyzing the injury mechanism. In order to record and subsequently analyze these during the procedure, an optical method, for example, can be used. However, other high-resolution methods are also applicable. An optical method must apply a frequency of 1000 Hz or more in order to be able to record sufficiently analyzable images over the short period of force application (≤ 5 ms). In order to be able to make statements about the defined speed, in this case the magnitude of the force acting on the specimens, this is measured directly during the procedure.According to video analysis, the impact force should be recorded at a frequency of at least 2000 Hz to fulfill the Shannon-Nyquist sampling theorem (Harry Nyquist: Certain Topics in Telegraph Transmission Theory. In: Transactions of the American Institute of Electrical Engineers. Vol. 47, 1928; Michael Unser: Sampling - 50 Years after Shannon. In: Proceedings of the IEEE. Vol. 88, No. 4, 2000, pp. 569-587).

[0118] In the device 100, 200, a gravitationally accelerated falling body is used as a defined mass. The adjustable drop height allows a consistent impact velocity to be applied to specimens of different lengths. The variable mass of the falling body can be used to generate the calculated force and energy upon impact of the defined mass on specimens of different lengths.

[0119] In a particular embodiment, the device 100, 200 has a solid base plate 101, 201 measuring 75 mm x 75 mm x 5 mm and weighing approximately 220 kg, two guide columns embedded therein, and two crossbeams running between the guide columns. The device 100, 200 has a height of 280 cm and is externally enclosed by a cladding 227 made of aluminum profiles and Makrolon panes. The upper crossbeam 115, 215 serves to stabilize the guide columns 118, 218. The vertically stably guided drop body of the device 100, 200 comprises a mass 112, 212 and one or more additional weights 113, 213 for adjusting the defined mass. The defined mass is held at the initial height by an electromagnet (Kendrion GmbH, Donaueschingen) and represents the holding mechanism 114, 214 of the device 100, 200.During vertical fall, the defined mass glides almost frictionlessly and gravitationally accelerated toward specimen 106. The height of the falling body is variable and can be adjusted from 50 to 110 cm using an adjusting rod 117. Likewise, the mass can be increased from 11.8 kg (empty weight) to up to 27 kg using additional weights 113, 213. Below this is a crossbeam 109, 209, which is either height-adjustable or not. A height-adjustable crossbeam can be adapted to the length of the specimens 106. The crossbeam 109, 209 serves for the upper clamping (alignment in a defined geometry and fixation) of the specimens 106 and contains an axially guided and friction-free impact punch 111, 211. This punch transfers the momentum of the falling body to the specimen 106.The crosshead 109, 209 can contain one or more force sensors 103, preferably three force sensors 103 (type 9011A Kistler, Winterthur, Switzerland), which measure the force occurring when the falling body impacts the impact punch 111, 211 (and thus the specimen 106). In order to be able to absorb the falling body during impact, the crosshead 109, 209 contains at least one damping device 110, 210, preferably shock absorbers, preferably two industrial shock absorbers (ACE SCS33-25EU, ACE Stoßdämpfer GmbH, Langenfeld). These two shock absorbers can together absorb a maximum energy of 310 J over a braking distance of 2.6 mm and are also height-adjustable (65 mm). This adjustment option allows the impact of the defined mass onto the specimen 106 to be dampened or undamped.

[0120] Below the crosshead 109, 209 is a base plate 101, 201 for the lower clamping of the specimens 106. The base plate 101, 201 comprises means for securing the specimen 106, for example, a carriage that can be moved translationally on the base plate and, if appropriate, a mold 105 fastened thereto, for example, a pouring pot. One or more force sensors 103 (e.g., type 9061A, Kistler, Winterthur, Switzerland) can be clamped between the mold 105 and the means for securing the specimen 106. Using the upper and lower clamping options, specimens 106 can be fixed in various defined geometries in the device 100, 200 and preferably positioned centrally under the striking punch 111, 211. This also makes it possible to predetermine a defined position of the joints of a specimen 106, for example, pronation or supination.

[0121] The adjusting rod 117 in the device 100 is used to adjust the height of the fall. The height adjustment can also be achieved by other means, for example, via a cable pull, electric cable winch, or bolt-on system.

[0122] In a preferred embodiment of the device 200, the focus is on the cost-effectiveness, robustness, and transportability of the device 200. This device 200 is preferably used to reproducibly create defined bone fractures in specimens for customer orders. Therefore, this device 200 preferably does not have any measuring technology. This allows for faster and more effective work with the device 200. The components are preferably made of steel alloys rather than aluminum to enable a longer material life and less wear over longer operating times. A commercial device 200 preferably comprises at least two modules that can be separated for easy transport. The specimens 106 are clamped in the lower module 400 (working module).Module 400 is designed so that all adapters and other tools for clamping specimens 106 in a defined geometry can be used to align specimen 106 in the defined geometry. The dimensions of the workspace have been increased in all three directions to enable faster work. The upper module 300 (drive module) has been expanded to include several components. The reason for this is to increase the cost-effectiveness of fixture 200 and to make work on fixture 200 safer. A drop body is magnetically held on two approximately 2 m long, vertical guide columns 218. When released, the drop body slides along the guide columns 218 to the impact punch 211. The settings for the drop height and the defined mass can be performed by a single person. For this purpose, the holding mechanism 214 for the defined mass is controlled so that the holding mechanism 214 is not accidentally triggered.For example, by programming the electrically controlled holder of two magnets to be permanently magnetic, i.e., to hold the defined mass. Only when these magnets receive the electrical command controlled via a safety lock do they release the connection to the defined mass (the test body). A power failure or other technical fault cannot thus interrupt the holding mechanism 214. Additionally, the test body is mechanically secured during operation in the working and / or drive module 329, 229, 400 by locking bolts, which are only removed immediately before the fall. The (free) fall of the test body is triggered by an electrical signal to the magnets. To lift the test body again, a crossbar 215, 315 is lowered along the guide columns 218, 318 within the drive module 300, which is connected to the test body via the above-described magnetic system.The assembly is then pulled upwards via a pulley 225. The release of the masses 212, 312 is also triggered by a push-button safety switch 226, 326 of the same design, and cannot be affected by a power failure or other technical malfunction. Furthermore, the masses 212, 312 are additionally secured by safety bolts inserted into the holes 221, 321.

[0123] In another exemplary embodiment of the device 200, it comprises a mounting module 430, 230 and a drive module 329, 229. This device 200 is particularly suitable for commercial applications because the two modules can be easily separated, transported, and reassembled to form the device 200. The entire device 200 has a height of 315 cm.

[0124] The add-on module 430, 230 comprises a base plate 401 (e.g., 70 cm x 82 cm) on which two support columns 419 are mounted, for example, spaced 54 cm apart. The support columns 419 have a height of at least 50 cm, preferably 110 cm, and support the crossbeam 409 with the integrated impact stamp 411. Various clamping devices or adapters can be attached to the underside of the impact stamp 411. In the add-on module 430, 230, the crossbeam 409 is either height-adjustable or non-adjustable. Preferably, the crossbeam 409 is not height-adjustable so that the working height is kept constant and the base plate 401, on which the specimen 106 is mounted, is adapted to the height of the impact stamp 411. This adjustment is carried out, for example, using tables (e.g. with an area of ​​40 x 40 cm) with different heights, which can be screwed into the base plate using holes 402.If necessary, one or more means for adjusting the damping, for example two shock absorbers, are installed in the cross member 409.

[0125] The generation of the force impulse in the drive module 329, 229 is based on the same technology as in the device 100. The drive module 329, 229 comprises at least one guide column 318, preferably two, for example, 190 cm long guide columns 318. The guide columns 318 can have holes 321, for example, at 3 cm intervals. These holes 321 serve to place the securing bolts and to securely position the defined mass. The mass 312 and at least two additional cross members 315 and 315 run on the guide columns 318. The mass 318 has a dead weight of, for example, 18 kg and can be adjusted to a defined mass using additional weights 315, for example, a defined mass of max. 72 kg.

[0126] The drive module preferably comprises safety mechanisms to prevent accidents when carrying out the method according to the invention. The following non-limiting examples of corresponding safety mechanisms can be part of the drive module 300, individually or in combination.

[0127] At least two holding mechanisms 314 are located on the mass 318, e.g., two docking plates, to which permanent magnets can dock on the underside of the crosshead 315. The permanent magnets fit onto the docking plates of the falling mass.

[0128] The crossbeam 315 can be moved, for example, via a cable pulley 225 (with, for example, three pulleys). It serves to safely raise the drop mass after the procedure has been completed. Once the magnets have docked onto the drop mass, the drop mass can be lifted with the connected crossbeam 315 via the cable pulley 225.

[0129] At least one pin of an electrical plug-in signal generator and two additional docking plates can be located on the top side of the crossbeam 315. If the crossbeam 315 is lifted below the crossbeam 315 (where the appropriate inlet for pin 323 is located), pin 322 on the crossbeam 315 connects with the inlet for pin 323 on the underside of the crossbeam 315. This closes an electrical lock. Simultaneously, the docking plates of the crossbeam 315 connect with the permanent magnets of the crossbeam 315. This firmly connects the crossbeam 315 and the crossbeam 315 and the drop mass. The crossbeam 315 serves to hold this assembly and to regulate the drop height. The crossbeams 315 and 7 or the crossbeam 315 are held in the guide columns 318 by safety bolts. To adjust the drop height, the safety bolts must be removed.Below the falling mass, securing can also be provided by means of safety bolts in the holes 321 of the guide column 318.

[0130] To release the drop mass for the process, the polarity of the permanent magnets on the crossbeams 315 and 315 must be reversed. This is done via an electrical signal. This means that the drop mass is only released by the magnets when current is flowing. If the device 200 is disconnected from the electrical connection, the drop mass cannot fall. The electrical signal that triggers the free fall of the mass is generated via a safety switch 226, 326 on the outside of the drive module 300. The safety switch 226, 326 must be released manually using a key and triggered by an additional button press. The signal from the safety switch 226, 326 can only be triggered if the crossbeams 315 and 315 are properly connected to the drop mass via the plug-in signal generators 322 and 323.

[0131] Both the body and drive modules 329, 229, 400 are surrounded by an opaque covering 227, 327, 427 (e.g., sheet metal covering). The coverings are, for example, Makrolon panes and / or sheet metal coverings. This prevents a person from reaching into the device 200 and injuring themselves while carrying out the method according to the invention.

[0132] A device 500, 600 with measuring technology is used to validate the theoretically calculated defined geometry of the specimen 106 with respect to the defined direction from which the defined mass impacts the specimen 106, to validate the theoretically calculated defined compression of the specimen 106 upon impact of the defined mass, to validate the theoretically calculated defined damping upon impact of the defined mass, and to validate the theoretically calculated defined velocity of the defined mass. Appropriate measuring technology can be used to improve the hit rate for generating the defined bone fracture.The structure and evaluation are known from Robert Holz (2013) (Master’s thesis “The mechanism of the Essex Lopresti: Investigation of tissue failure using a newly developed simulator”), Marc Ebinger (2013) (Master’s thesis “Design and evaluation of a novel simulator for high-speed injuries of the human forearm”) and Dieter Fink (2013) (Master’s thesis “Conception and creation of a software package for synchronization, data acquisition and measurement signal display for the Essex Lopresti simulator”).

[0133] The figures serve to describe devices suitable for carrying out the method according to the invention and for producing the preparations according to the invention.

[0134] Fig.1: Device 100 comprising base plate 101, means for fixing the specimen 102, force sensor 103, specimen 106, clamping plate 107, ball bearing 108, cross member 109 with impact stamp 111, means for adjusting the damping 110, mass 12112 and additional weight 113, holding mechanism 114, cross member 115, roof 116, adjusting rod 117, guide column 118.

[0135] Fig. 2: Device 200 comprising drive module 229 and superstructure module 230, base plate 1201, clamping plate 207, cross member 209 with impact stamp 211, means for adjusting the damping 210, mass 212, additional weight 213, holding mechanism 214, cross member 215, roof 216, guide column 218, support column 219, docking plate 220, bore 221, pin for signal generator 222, inlet for the pin 223, cross member 224, pulley 225, safety switch 226, cover 227.

[0136] Fig.3: Drive module 329 for a device 200 comprising mass 312, additional weight 315, holding mechanism 314, cross member 315, roof 316, guide column 318, docking plate 320, bore 321, pin for signal generator 322, inlet for pin 323, cross member 315, safety switch 326, cover 327.

[0137] Fig. 4a: Mounting module 430 for a device 200 with closed cover 427

[0138] Fig. 4b: Mounting module 430 for a device 200 with open cover 427, base plate 401, means for fixing the specimen 402, clamping plate 407, non-height-adjustable cross member 409 with striking stamp 411.

[0139] Fig.5: Device 500 for confirming the calculated parameters and for establishing the method according to the invention using the calculated parameters, comprising a clamped specimen 506 cast in a mold 505 at the proximal and distal ends, cameras 528, and force sensors 503. One mold 505 is attached to the means for fixing the specimen 502, and the second mold 505 is attached to the clamping plate 507. The device 500 comprises base plate 501, height-adjustable crosshead 509 with impact punch 511, mass 512 with additional weight 513, adjusting rod 517, and guide columns 518.

[0140] Fig. 6: Experimental setup with device 600 for confirming the calculated parameters and for establishing the method according to the invention using the calculated parameters.

[0141] The following examples serve to illustrate the method according to the invention and the human preparations according to the invention, which comprise a defined bone fracture. However, the invention is not limited to the preparations with defined bone fractures that can already be produced reproducibly, but can be applied to other defined bone fractures that can be created in preparations in a manner analogous to that explained in the description and examples.

[0142] Example 1: Alignment in a defined geometry for the reproducible creation of shaft fractures of phalanges I - V (78 A2, B2, C2 according to AO).

[0143] For a shaft fracture of the phalanges I - V (78 A2, B2, C2 according to AO), a specimen 106 consisting of hand and forearm is used.

[0144] To align the specimen 106 in the defined geometry, the forearm is lowered approximately 6–10 cm distal to the elbow. At the proximal end of the forearm stump, approximately 5 cm of the soft tissue around the radius and ulna is removed, and the bones are cast vertically in a mold 105 using cold-curing polymer. The mold 105 is connected in the device 100 to the clamping plate 107 on the impact punch 111. The cut surfaces of the radius and ulna are centrally located below the force application point. In this vertical position, the wrist is held in the neutral position, and the phalanges of the relevant finger joints are inserted into an adapter (11 or 12). The phalanges should be in a vertical line, an imaginary extension, below the radius and ulna. The dead weight of the impact punch 111 holds the specimen 106 in the desired position in this clamping position. The adapter (11 or 12) is supported flat on the base plate 101 of the device 100.With the inserted finger joints, the hand should not be moved sideways from the neutral position, or only if it is not rigid but rather deflects under the weight of the impact punch 111. The direction and amount by which the adapter is moved on the base plate with the inserted finger joints depends on the specimen.

[0145] The following settings are made on the device 100: The defined mass (falling mass) is 5.2 to 9.8 kg, the defined speed is set by means of the fall height to 29 to 46 cm, the defined compression is set to 2 to 8 mm, and the defined damping is set by the damped portion of the defined compression to 0 to 5 mm. The holding mechanism 114 is triggered, and a shaft fracture of the phalanges I - V, 78 A2, B2, C2 according to AO is created in the specimen 106 with a probability of 86%.

[0146] Example 2: Alignment in a defined geometry for the reproducible creation of shaft fractures of metacarpals I - V (77 A2, B2, C2 according to AO).

[0147] For a shaft fracture of the metacarpals I - V, (77 A2, B2, C2 according to AO) a specimen 106 consisting of hand and forearm is used.

[0148] To align specimen 106 in the defined geometry, the forearm is lowered approximately 6-10 cm distal to the elbow. The specimen 106 is placed flat on a straight plate with the palm facing down, and the forearm is secured in a supination position using tensioning straps. An adapter (6 or 7) is attached to the underside of the impact punch 111 in the device 100. The pin of the adapter is perpendicular, with the rounded side facing specimen 106 below the impact punch 111. The end of the adapter is positioned centrally over the desired fracture site.

[0149] If necessary, one or more foam mats are applied between the surface of the adapter and the specimen 106 (depending on the specimen). The foam mats prevent the adapter from slipping off the targeted fracture site and passively increase the area of ​​force transmission. With the help of the foam mats, the skin of the fractured specimen 106 remains intact.

[0150] The following settings are made on the device 100: The defined mass (falling mass) 7 to 11.2 kg, the defined speed by means of the fall height to 35 to 52 cm, the defined compression to 6 to 14 mm and the defined damping by the damped part of the defined compression to 0 to 9 mm.

[0151] The holding mechanism is triggered and a shaft fracture of the metacarpals I - V, 77 A2, B2, C2 according to AO is produced with a probability of 79% in specimen 106.

[0152] Example 3: Alignment in a defined geometry for the reproducible creation of a distal radius fracture (extension, 23 A2, 23 C1 - C3 dorsal to AO).

[0153] For a distal radius fracture of classification 23 A2, 23 C1 - C3 (dorsal) according to AO, a specimen 106 consisting of hand, forearm and upper arm is selected.

[0154] To align the specimen 106 in the defined geometry, the upper arm is lowered approximately 10–12 cm distal to the humeral head. Approximately 5 cm of soft tissue is removed from the humeral stump, and the humeral bone is cast vertically in a mold 105 using cold-curing polymer. The mold 105 is connected in the device 100 to the clamping plate 107 on the impact die 111. The cut surface of the humerus is positioned centrally below the force application point. The humeroulnar joint is flexed from maximum extension (usually between 176 and 189 degrees; the angle depends on the specimen) by 10 to 12 degrees. In this position, the forearm is rotated from maximum supination to a pronation of 60 to 70 degrees. The wrist is extended to the maximum (maximum means 59 - 68 degrees depending on the preparation) from the neutral position and supported on an adapter 04.

[0155] The following settings are made on the device 100: The defined mass (falling mass) 16.8 to 19.3 kg, the defined speed by means of the fall height to 76 to 102102 cm, the defined compression to 22 to 30 mm and the defined damping by the damped part of the defined compression to 6 to 14 mm.

[0156] The holding mechanism 114 is triggered and the distal radius fracture of classification 23 A2, 23 C1 - C3 (dorsal) according to AO is created with a probability of 90% in the specimen 106.

[0157] Example 4: Alignment in a defined geometry for the reproducible creation of a distal radius fracture (flexion, 23 A2, palmar to AO)

[0158] For a distal radius fracture of classification 23 A2 (palmar) according to AO, a specimen 106 consisting of hand, forearm and upper arm is prepared.

[0159] To align the specimen 106 in the defined geometry, the upper arm is lowered approximately 10–12 cm distal to the humeral head. Approximately 5 cm of soft tissue is removed from the humeral stump, and the humeral bone is cast vertically in a mold 105 using cold-curing polymer. The mold 105 is connected in the device 100 to the clamping plate 107 on the impact punch 111. The cut surface of the humerus is positioned centrally below the force application point. The humeroulnar joint is flexed from maximum extension (usually between 176 and 189 degrees; the angle depends on the specimen) by 10 to 12 degrees. In this position, the forearm is rotated from maximum supination to a pronation of 50 to 60 degrees. The wrist is flexed by 45 - 58 degrees (starting from the neutral position) and supported on a flat surface against the base plate 101 of the device 100.

[0160] The following settings are made on the device 100: The defined mass (fall mass) is 16.8 to 20.5 kg, the defined speed is set by means of the fall height to 82 to 102 cm, the defined compression is set to 25 to 35 mm, and the defined damping is set by the damped portion of the defined compression to 5 to 17 mm. The holding mechanism 114 is triggered, and the distal radius fracture of classification 23 A2 (palmar) according to AO is created in the specimen 106 with a probability of 86%.

[0161] Example 5: Alignment in a defined geometry for the reproducible creation of a distal radius fracture / die-punch fracture (conditionally 23 C1 - C2 according to AO).

[0162] For a distal radius fracture die-punch fracture of classification (conditional) 23 C1 - C2 according to AO, a specimen 106 consisting of hand, forearm and upper arm is prepared.

[0163] To align the specimen 106 in the defined geometry, the upper arm is lowered approximately 10–12 cm distal to the humeral head. Approximately 5 cm of soft tissue is removed from the humeral stump, and the humeral bone is cast vertically in a mold 105 using cold-curing polymer. The mold 105 is connected in the device 100 to the clamping plate 107 on the impact punch 111. The cut surface of the humerus is centrally positioned below the force application point. The humeroulnar joint is flexed from maximum extension (usually between 176 and 189 degrees; the angle depends on the specimen) by 0 to 8 degrees. In this position, the forearm is rotated from maximum supination to a pronation of 45 to 52 degrees. The wrist is held in a neutral position and supported on an adapter 04 on the base plate 101 of the device 100. The hand encloses the handle bar of the adapter 04, the phalanges are bent.The hand thus forms a fist, which encloses the handle bar and supports it with the phalanges II - IV against the base plate 101 of the device 100.

[0164] The following settings are made on the device 100: The defined mass (fall mass) is 17 to 23.1 kg, the defined speed is set by means of the fall height to 90 to 10110 cm, the defined compression is set to 22 to 31 mm, and the defined damping is set by the damped portion of the defined compression to 9 to 15 mm. The holding mechanism 114 is triggered, and the distal radius fracture / die-punch fracture of classification (conditional) 23 C1 - C2 according to AO is created in the specimen 106 with a probability of 69%.

[0165] Example 6: Alignment in a defined geometry for the reproducible creation of a distal radius fracture chauffeur fracture (23 B1 according to AO).

[0166] For a distal radius fracture chauffeur fracture of classification 23 B1 according to AO, a specimen 106 consisting of hand, forearm and upper arm is prepared.

[0167] To align the specimen 106 in the defined geometry, the upper arm is lowered approximately 10–12 cm distal to the humeral head. Approximately 5 cm of soft tissue is removed from the humeral stump, and the humeral bone is cast vertically in a mold 105 using cold-curing polymer. The mold 105 is connected in the device 100 to the clamping plate 107 on the impact punch 111. The cut surface of the humerus is positioned centrally below the force application point. The humeroulnar joint is flexed from maximum extension (usually between 176 and 189 degrees; the angle depends on the specimen) by 0 to 8 degrees. In this position, the forearm is rotated from maximum supination to a pronation of 45 to 52 degrees. The wrist is extended 35 - 43 degrees from the neutral position and supported on an adapter 02 having a spherical surface on the base of the device 100.The support point should be located 3-8 cm (depending on the specimen) anterior to the humeral shaft / force application point in the transverse plane. The hand should be moved laterally on the round surface of the adapter 02 until it exhibits a radial abduction of 20 degrees (from the neutral position).

[0168] The following settings are made on the device 100: The defined mass (falling mass) is 16.6 to 18.3 kg, the defined speed is set by means of the fall height to 80 to 93 cm, the defined compression is set to 20 to 28 mm, and the defined damping is set by means of the damped portion of the defined compression to 6 to 14 mm. The holding mechanism 114 is triggered, and the distal radius fracture / chauffeur fracture (conditional) of classification 23 B1 according to AO is created in the specimen 106 with a probability of 75%.

[0169] Example 7: Alignment in a defined geometry for the reproducible creation of a scaphoid fracture (72 A2, B2 - B3 according to AO).

[0170] For a scaphoid fracture 72 A2, B2 - B3 according to AO, a specimen 106 consisting of hand and forearm is prepared.

[0171] To align the specimen 106 in the defined geometry, the forearm is lowered approximately 6-10 cm distal to the elbow. At the proximal end of the forearm stump, approximately 5 cm of the soft tissue around the radius and ulna is removed, and the bones are cast vertically in a mold 105 using cold-curing polymer. The mold 105 is connected in the device 100 to the clamping plate 107 on the impact punch 111. The cut surfaces of the radius and ulna are centrally located below the force application point. In this vertical position, the wrist is extended 35-50 degrees from the neutral position and supported on an adapter 04 on the base plate 101. The support point lies 0-4 cm in the transverse plane behind the cast portions of the radius and ulna / force application point. On the cylindrical surface of the adapter 04, the hand is moved laterally until it has a radial abduction of 3 - 6 degrees (from the neutral position).

[0172] The following settings are made on the device 100: The defined mass (falling mass) is 16.8 to 19.5 kg, the defined speed is set by means of the fall height to 75 to 88 cm, the defined compression is set to 24 to 32 mm, and the defined damping is set by means of the damped portion of the defined compression to 10 to 17 mm. The holding mechanism 114 is triggered, and the scaphoid fracture of classification 72 A2, B2 - B3 according to AO is created in the specimen 106 with a probability of 60%.

[0173] Example 8: Alignment in a defined geometry for the reproducible creation of a radial head fracture (type I - III according to Mason, 21 B2 according to AO).

[0174] For a radial head fracture type I - III according to Mason, 21 B2 according to AO, a specimen 106 consisting of hand, forearm and upper arm is prepared.

[0175] To align the specimen 106 in the defined geometry, the upper arm is lowered approximately 10–12 cm distal to the humeral head. Approximately 5 cm of soft tissue is removed from the humeral stump, and the humeral bone is cast vertically in a mold 105 using cold-curing polymer. The mold 105 is connected in the device 100 to the clamping plate 107 on the impact punch 111. The cut surface of the humerus is centrally positioned below the force application point. The humeroulnar joint is flexed from maximum extension (usually between 176 and 189 degrees; the angle depends on the specimen) by 0 to 8 degrees. In this position, the forearm is rotated from the neutral position into a pronation of 45 to 52 degrees. The hand is secured in a fist position with bandages, and the wrist is stiffened in the neutral position. The bandaged part of the preparation is supported vertically in an adapter 16.If necessary, one or more foam mats are applied to the base of adapter 16 under the supported hand (depending on the specimen). Adapter 16 is filled with quartz sand and screwed onto base plate 101 of device 100. The adapter should be filled 12-15 cm from base plate 101. The support point on base plate 101 is located 3-8 cm (depending on the specimen) in front of the humeral shaft / force application point in the transverse plane.

[0176] These foam mats protect the biological structures in the wrist area by passively increasing the area of ​​force transmission. The foam mats prevent specimen 106 from fracturing below the intended position.

[0177] The following settings are made on the device 100: The defined mass (falling mass) is 18.3 to 21.5 kg, the defined speed is set by means of the fall height to 75 to 88 cm, the defined compression is set to 21 to 29 mm, and the defined damping is set by means of the damped portion of the defined compression to 9 to 15 mm. The holding mechanism 114 is triggered, and the radial head fracture of the Mason type I-III classification, 21 B2 according to AO, is created in the specimen 106 with a probability of 79%.

[0178] Example 9: Alignment in a defined geometry for the reproducible creation of a coronoid fracture (Regan & Morrey Type I - III, 21 B1 according to AO).

[0179] For a coronoid fracture Regan & Morrey type I - III, 21 B1 according to AO, a specimen 106 consisting of hand, forearm and upper arm is prepared.

[0180] To align the specimen 106 in the defined geometry, the upper arm is lowered approximately 10–12 cm distal to the humeral head. Approximately 5 cm of soft tissue is removed from the humeral stump, and the humeral bone is cast vertically in a mold 105 using cold-curing polymer. The mold 105 is connected in the device 100 to the clamping plate 107 on the impact punch 111. The cut surface of the humerus is centrally positioned below the force application point. The humeroulnar joint is held in maximum extension (usually between 176 and 189 degrees; the angle depends on the specimen) and the forearm is fixed in the neutral position. The hand is secured with bandages in a fist position, and the wrist is stiffened in the neutral position. The bandaged portion of the specimen 106 is supported vertically in an adapter 16. If necessary, one or more foam mats are applied to the bottom of the adapter 16 under the supported hand (depending on the preparation).The adapter 16 is filled with quartz sand and screwed onto the base plate 101. The adapter should be filled to a depth of 12–15 cm from the base. The support point on the base plate 101 is located 3–8 cm (depending on the specimen) in the transverse plane anterior to the humeral shaft / force application point.

[0181] The foam mats protect the biological structures in the wrist area by passively increasing the area of ​​force transmission. These foams prevent specimen 106 from fracturing below the intended position.

[0182] The following settings are made on the device 100: The defined mass (falling mass) is 18.2 to 22.8 kg, the defined speed is set by means of the fall height to 75 to 86 cm, the defined compression is set to 20 to 33 mm, and the defined damping is set by means of the damped portion of the defined compression to 8 to 16 mm. The holding mechanism 114 is triggered, and the coronoid fracture of the Regan & Morrey Type I - III, 21 B1 classification according to AO is created in the specimen 106 with a probability of 90%.

[0183] Example 10: Alignment in a defined geometry for the reproducible generation of a Terrible Triad (21 C1 according to AO).

[0184] For a Terrible Triad 21 C1 according to AO, a specimen 106 consisting of hand, forearm and upper arm is prepared.

[0185] To align the specimen 106 in the defined geometry, the upper arm is lowered approximately 10–12 cm distal to the humeral head. Approximately 5 cm of soft tissue is removed from the humeral stump, and the humeral bone is cast vertically in a mold 105 using cold-curing polymer. The mold 105 is connected in the device 100 to the clamping plate 107 on the impact punch 111. The cut surface of the humerus is centrally positioned below the force application point. The humeroulnar joint is flexed from maximum extension (usually between 176 and 189 degrees; the angle depends on the specimen) by 0 to 8 degrees. In this position, the forearm is rotated from the neutral position into maximum pronation. The hand is fixed with bandages in a fist position, and the wrist is stiffened in the neutral position. The bandaged portion of the specimen is supported vertically in an adapter 16.One or more foam mats are applied to the base of adapter 16 under the supported hand (depending on the specimen). Adapter 16 is filled with quartz sand and screwed onto base plate 101. The adapter should be filled 12–15 cm above base plate 101. The support point on base plate 101 is located 3–8 cm (depending on the specimen) in the transverse plane in front of the humeral shaft or force application point.

[0186] These foam mats protect the biological structures in the wrist area by passively increasing the area of ​​force transmission. These foams prevent specimen 106 from fracturing below the intended position.

[0187] The following settings are made on the device 100: The defined mass (falling mass) is 18.9 to 26.8 kg, the defined speed is set by means of the fall height to 85 to 100 cm, the defined compression is set to 24 to 38 mm, and the defined damping is set by the damped portion of the defined compression to 10 to 18 mm. The holding mechanism 114 is triggered, and the Terrible Triad of classification 21 C1 according to AO is generated in the specimen 106 with a probability of 92%.

[0188] Example 11: Alignment in a defined geometry for the reproducible creation of an olecranon fracture (21 B1, C1 according to AO).

[0189] For an olecranon fracture 21 B1, C1 according to AO, a specimen 106 consisting of hand, forearm and upper arm is prepared.

[0190] To align the specimen 106 in the defined geometry, the humerus is set approximately 6-10 cm distal to the humeral head. At the proximal end of the humeral stump, approximately 5 cm of soft tissue is removed, and the bone is cast vertically in a mold 105 using cold-curing polymer. The mold 105 is connected to the clamping plate 107 on the impact punch 111 in the device 100 according to the invention. The cut surface of the humerus is positioned centrally below the force application point. The humeroulnar joint is flexed 90 degrees, and the olecranon is supported on an adapter 03 in the shape of a truncated cone on the base plate 101 of the device 100. The forearm should be held in supination. The support point lies in the transverse plane below the cast humerus.

[0191] The following settings are made on the device 100: The defined mass (fall mass) is 17.1 to 20 kg, the defined speed is set by means of the fall height to 61 to 79 cm, the defined compression is set to 4 to 17 mm, and the defined damping is set by means of the damped portion of the defined compression to 0 to 9 mm. The holding mechanism 114 is triggered, and the olecranon fracture of classification 21 B1, C1 according to AO is created in the specimen 106 with a probability of 94%.

[0192] Example 12: Alignment in a defined geometry for the reproducible creation of a Monteggiafracture (21 A1, B1 according to AO).

[0193] For a Monteggiasi fracture 21 A1, B1 according to AO, a specimen 106 consisting of hand, forearm and upper arm is prepared.

[0194] To align the specimen 106 in the defined geometry, the humerus is placed approximately 10-12 cm distal to the humeral head. At the proximal end of the humeral stump, approximately 5 cm of soft tissue is removed, and the bone is cast vertically in a mold 105 using cold-curing polymer. The mold 105 is connected in the device 100 according to the invention to means for fixing the specimen 102, for example, an adjustable slide on the base plate 101. The cut surface of the humerus is positioned centrally below the force application point. The specimen 106 is thus positioned in the device 100 with the ulna / olecranon facing upwards. An adapter 18 is attached to the clamping plate 107 below the impact punch 111. The forearm is clamped in it from the medial and laterally. The flexion angle of the humeroulnar joint is between 90 and 100 degrees. The adapter's support point on the ulna is located 4-6 cm anterior to the fusion site in the transverse plane.7-9 cm distal to the olecranon tip, on the radius 2-5 cm in front of the injection site / 5-7 cm distal to the olecranon tip. The forearm is fixed in maximum supination.

[0195] The following settings are made on the device 100: The defined mass (falling mass) is 16.8 to 17.9 kg, the defined speed is set by means of the fall height to 72 to 88 cm, the defined compression is set to 28 to 46 mm, and the defined damping is set by means of the damped portion of the defined compression to 10 to 17 mm. The holding mechanism 114 is triggered, and the Monteggia fracture of classification 21 A1, B1 according to AO is created in the specimen 106 with a probability of 60%.

[0196] Example 13: Alignment in a defined geometry for the reproducible creation of a Monteggia-like lesion (21 B3 according to AO).

[0197] For a Monteggia-like lesion 21 B3 according to AO, a specimen 106 consisting of hand, forearm and upper arm is prepared.

[0198] To align the specimen 106 in the defined geometry, the humerus is lowered approximately 10-12 cm distal to the humeral head. At the proximal end of the humeral stump, approximately 5 cm of soft tissue is removed, and the bone is cast vertically in a mold 105 using cold-curing polymer. The mold 105 is connected in the device 100 to means for fixing the specimen 102, for example, an adjustable slide on the base plate 101. The cut surface of the humerus is positioned centrally below the force application point. The specimen 106 is thus positioned in the device 100 with the ulna / olecranon facing upwards. An adapter 18 is attached to the clamping plate 107 below the impact punch 111. The forearm is clamped in it from the medial and laterally. The flexion angle of the humeroulnar joint should be between 80 and 95 degrees. The support point of the adapter on the ulna should be 3 - 5 cm in front of the casting point in the transverse plane.Stand 6-7 cm distal to the olecranon tip, on the radius 2-5 cm in front of the casting site / 5-7 cm distal to the olecranon tip. The forearm must be fixed in maximum supination.

[0199] The following settings are made on the device 100: The defined mass (falling mass) is 16.8 to 18.4 kg, the defined speed is set by means of the fall height to 75 to 92 cm, the defined compression is set to 30 to 46 mm, and the defined damping is set by means of the damped portion of the defined compression to 9 to 21 mm. The holding mechanism 114 is triggered, and the Monteggia-like lesion of classification 21 B3 according to AO is created in the specimen 106 with a probability of 66%.

[0200] Example 14: Alignment using a defined geometry for the reproducible creation of a Galeazzi fracture (22 A3, B3, C1 - C3 according to AO).

[0201] For a Galeazzi fracture 22 A3, B3, C1 - C3 according to AO, a specimen 106 consisting of hand, forearm and upper arm is prepared.

[0202] To align the specimen 106 in the defined geometry, the upper arm is lowered approximately 10-12 cm distal to the humeral head. Approximately 5 cm of soft tissue is removed from the humeral stump, and the humeral bone is cast vertically in a mold 105 using cold-curing polymer. The mold 105 is connected to the clamping plate 107 on the impact punch 111 in the device 100 according to the invention. The cut surface of the humerus is positioned centrally below the force application point. The humeroulnar joint is flexed 5 to 12 degrees from maximum extension (usually between 176 and 189 degrees; the angle depends on the specimen). In this position, the forearm is rotated from the neutral position into maximum supination. The wrist is fixed with bandages in an extension position of 80-90 degrees and supported vertically in an adapter 16. On the bottom of the adapter 16, various foam mats are applied under the supported hand (depending on the preparation).These foam mats (available in three different degrees of hardness) protect the biological structures in the wrist area by passively increasing the area of ​​force transmission. These foams prevent the specimen 106 from fracturing below the targeted position. The adapter 16 is filled with quartz sand and screwed onto the base plate 101 of the device 100. The adapter should be filled 6-8 cm from the base. The support point on the base plate 101 should be located 3-8 cm (depending on the specimen) in the transverse plane anterior to the humeral shaft / force application point.

[0203] The following settings are made on the device 100: The defined mass (drop mass) is 18.5 to 22.6 kg, the defined speed by means of the drop height is 95 to 107 cm, the defined compression is 24 to 39 mm, and the defined damping by the damped portion of the defined compression is 6 to 17 mm. The holding mechanism 114 is triggered and the Galeazzi fracture of the AO classification 22 A3, B3, C1 - C3 is generated in the specimen 106 with a probability of 53%.

[0204] Example 15: Orientation in a defined geometry for reproducible generation of a capitulum fracture (13 B3 according to AO).

[0205] For a capitulum fracture 13 B3 according to AO, a specimen 106 consisting of hand, forearm and upper arm is prepared.

[0206] To align the specimen 106 in the defined geometry, the humerus is lowered approximately 10-12 cm distal to the humeral head. At the proximal end of the humeral stump, approximately 5 cm of the soft tissue around the tibia and fibula is removed, and the bones are cast vertically in a mold 105 using cold-curing polymer. The mold 105 is connected in the device 100 to means for fixing the specimen 102, for example, an adjustable slide on the base plate 101. The cut surface of the humerus is positioned centrally below the force application point. The specimen 106 is thus positioned in the device 100 with the ulna / olecranon facing upwards. An adapter 05 or 08 is attached to the clamping plate 107 below the impact punch 111. The ulna is supported flat against the inclined surface of the adapter 05 or 08. The flexion angle of the humeroulnar joint should be between 90 and 115 degrees.The support point of the olecranon should be in the transverse plane above the casting point, and the forearm should be fixed in maximum supination.

[0207] The following settings are made on the device 100: The defined mass (falling mass) is 20.5 to 24.2 kg, the defined speed is set by means of a fall height of 70 to 81 cm, the defined compression is set by means of 14 to 22 mm, and the defined damping is set by means of the damped portion of the defined compression is set by means of 6 to 13 mm. The holding mechanism 114 is triggered, and the capitulum fracture of classification 13 B3 according to AO is created in the specimen 106 with a probability of 72%.

[0208] Example 16: Alignment in a defined geometry for the reproducible creation of a distal humerus fracture (13 B1, B2, C1 - C3 according to AO).

[0209] For a distal humerus fracture 13 B1, B2, C1 - C3 according to AO, a specimen 106 consisting of hand, forearm and upper arm is prepared.

[0210] To align the specimen 106 in the defined geometry, the humerus is set approximately 16-20 cm distal to the humeral head. At the proximal end of the humeral stump, approximately 5 cm of soft tissue is removed, and the bone is cast vertically in a mold 105 using cold-curing polymer. The mold 105 is connected in the device 100 to means for fixing the specimen 102, for example, an adjustable slide on the base plate 101. The cut surface of the humerus is positioned centrally below the force application point. The specimen 106 is thus positioned in the device 100 with the ulna / olecranon facing upwards. An adapter 05, 09, or 10 is attached to the clamping plate 107 below the impact punch 111. The ulna is supported flat against the inclined surface of the adapter 05, 09, or 10. The flexion angle of the humeroulnar joint should be between 120 and 150 degrees.The support point of the olecranon should be in the transverse plane above the casting point, and the forearm should be fixed in maximum supination.

[0211] The following settings are made on the device 100: The defined mass (fall mass) is 20.2 to 27.2 kg, the defined speed is set by means of the fall height to 68 to 81 cm, the defined compression is set to 26 to 37 mm, and the defined damping is set by means of the damped portion of the defined compression to 0 to 15 mm. The holding mechanism 114 is triggered, and the distal humerus fracture of classification 13 B1, B2, C1 - C3 according to AO is created in the specimen 106 with a probability of 79%.

[0212] Example 17: Alignment in a defined geometry for the reproducible creation of a clavicular shaft fracture (type A and B according to AO).

[0213] For a clavicular shaft fracture type A and B according to AO, a specimen 106 consisting of humerus, scapula, clavicle and sternal attachment is prepared.

[0214] To align the specimen 106 in the defined geometry, the upper arm is lowered approximately 10-12 cm distal to the humeral head. Approximately 3 cm of soft tissue is dissected from the humeral stump. On the scapula, the inferior angle is severed 7-8 cm below the horizontal so that the cut edge runs parallel to the scapular spine. The scapula and humerus are cast vertically on their cut edges in an adapter 12 using cold-curing polymer to a depth of approximately 3 cm. The vertical alignment of the scapula on the cut edge below the spine without lateral tilting must be ensured. The adapter 12 is then connected in the device 100 to means for fixing the specimen 102, for example, an adjustable slide on the base plate 101. An adapter 03 with the shape of a blunt cone is integrated on the clamping plate 107 below the striking punch 111.Means for securing the specimen 102, such as an adjustable slide, are positioned on the base plate 101 such that the targeted (marked) fracture site of the clavicle is centrally located under the force application point / adapter 03. For all clavicular shaft fractures types A and B, the marker is located at the transition of the S-shaped oscillation (5-8 cm medial to the sternal attachment). The medial end of the clavicle is fixed in a clamping ring on a height-adjustable adapter 14. Within the clamping ring is a 5 mm thick foam that allows minimal movement of the clavicle in all directions. The height of the medial end is adjusted to the height of the lateral end / humeral head.

[0215] The following settings are made on the device 100: The defined mass (fall mass) is 12.3 to 16.5 kg, the defined speed is set by means of a fall height of 55 to 68 cm, the defined compression is set by means of 4 to 12 mm, and the defined damping is set by means of the damped portion of the defined compression is set by means of 0 to 6 mm. The holding mechanism 114 is triggered, and the clavicular shaft fracture of the AO Type A and B classification is created in the specimen 106 with a probability of 70%.

[0216] Example 18: Alignment in a defined geometry for the reproducible creation of a lateral clavicle fracture (types I and II according to Neer).

[0217] For a lateral clavicle fracture type I and II according to Neer, a specimen 106 consisting of humerus, scapula, clavicle and sternal attachment is prepared.

[0218] To align the specimen 106 in the defined geometry, the upper arm is lowered approximately 10-12 cm distal to the humeral head. Approximately 3 cm of soft tissue is dissected from the humeral stump. On the scapula, the inferior angle is severed 7-8 cm below the horizontal so that the cut edge runs parallel to the scapular spine. The scapula and humerus are cast vertically on their cut edges in an adapter 12 using cold-curing polymer to a depth of approximately 3 cm. The vertical alignment of the scapula on the cut edge below the spine without lateral tilting must be ensured. The adapter 12 is then connected in the device 100 to means for fixing the specimen 102, for example, an adjustable slide on the base plate 101. An adapter 02 with a spherical surface is integrated on the clamping plate 107 below the impact punch 111.The means for securing the specimen 102, such as the slide, is positioned on the base plate 101 so that the targeted fracture site of the clavicle is centrally located under the force application point / adapter 02. For all of the above-mentioned fractures, the marking should be in the shoulder triangle (between the clavicle, coracoid process, and acromion). The medial end of the clavicle is secured in a clamping ring on a height-adjustable adapter 14. Within the clamping ring is a 5 mm thick foam that allows minimal movement of the clavicle in all directions. The height of the medial end is adjusted to the height of the lateral end / humeral head.

[0219] The following settings are made on the device 100: The defined mass (falling mass) is 10.3 to 21.9 kg, the defined speed is set by means of the fall height to 57 to 76 cm, the defined compression is set to 4 to 14 mm, and the defined damping is set by means of the damped portion of the defined compression to 0 to 7 mm. The holding mechanism 114 is triggered, and the lateral clavicle fracture of the Neer Type I and II classification is created in the specimen 106 with a probability of 52%.

[0220] Example 19: Alignment in a defined geometry for the reproducible creation of a proximal humerus fracture (11 B1, B3, C1 - C3 according to AO).

[0221] For a proximal humerus fracture 11 B1, B3, C1 - C3 according to AO, a specimen 106 consisting of humerus, scapula, clavicle and sternal attachment is prepared.

[0222] To align the specimen 106 in the defined geometry, the upper arm is lowered approximately 16–20 cm distal to the humeral head. Approximately 5 cm of soft tissue is removed from the humeral stump, and the humeral bone is cast vertically in a mold 105 using cold-curing polymer. The scapula is exposed approximately 3 cm along its medial margin (margo medialis) and cast with the medial edge in an adapter 12 using cold-curing polymer to a depth of approximately 3 cm. It is essential to ensure the vertical alignment of the scapula on the medial margin without lateral tilting. While the polymer is curing, the humerus should be held in a 90-degree abduction position to simulate its subsequent position in the device 100. The adapter 12 is then connected in the device 100 to means for fixing the preparation 102, for example an adjustable carriage on the base plate 101.In the device 100 according to the invention, the mold 105 is connected to the clamping plate 107 on the impact punch 111. The cut surface of the humerus is positioned centrally below the force application point. The means for securing the specimen 102, for example, the adjustable slide, is positioned on the base plate 101 such that the fixed humerus is at an abduction angle of 85-95 degrees in the acetabulum of the scapula. Furthermore, the humerus should exhibit an internal rotation of 10-15 degrees relative to the scapula.

[0223] The following settings are made on the device 100: The defined mass (fall mass) is 19.2 to 28.8 kg, the defined speed is set by means of the fall height to 65 to 88 cm, the defined compression is set to 29 to 44 mm, and the defined damping is set by the damped portion of the defined compression to 0 to 16 mm. The holding mechanism 114 is triggered, and the proximal humerus fracture of classification 11 B1, B3, C1 - C3 according to AO is created in the specimen 106 with a probability of 76%.

[0224] Example 20: Alignment in a defined geometry for the reproducible creation of a distal femur fracture (33 C1 - C3 according to AO).

[0225] For a femur fracture 33 C1 - C3B3 according to AO, a specimen 106 consisting of foot, lower leg and thigh is clamped.

[0226] To align the specimen 106 in the defined geometry, the foot is placed on the base plate 101 of the device 100, the knee joint is flexed between 110 degrees and 130 degrees, and secured with an adapter 17 under the impact punch 111. The adapter 17 is based on the model of an inverted vise. This means that it applies a parallel clamping force from two sides (lateral and medial) to the selected specimen 106. This securely fixes the specimen 106. The adapter is screwed to the impact punch 111. The impulse is thus transmitted directly to the specimen 106. The adapter 17 has a shaft joint, which can be used to adjust the surface that presses on the femur. This allows the force application point in the joint to be precisely and fracture-specifically controlled. The knee joint should be positioned 4 - 8 cm in front of the ankle joint in the transverse plane, the inner angle of the knee joint should be between 100 degrees and 130 degrees.Tibial rotation should not be affected. Lateral flexion (varus / valgus) should also not be affected, but should not exceed 5 degrees.

[0227] The following settings are made on the device 100: The defined mass (fall mass) is 26.0 to 38.7 kg, the defined speed is set by means of the fall height to 99 to 116 cm, the defined compression is set to 31 to 49 mm, and the defined damping is set by means of the damped portion of the defined compression to 0 to 37 mm. The holding mechanism 114 is triggered, and the distal femur fracture of classification 33 C1-C3 according to AO is created in the specimen 106.

[0228] Example 21: Alignment in a defined geometry for the reproducible creation of a tibial head fracture (41 B1 according to AO).

[0229] For a (proximal) tibial head fracture of classification 41 B1 according to AO, a specimen 106 consisting of foot, lower leg and thigh is clamped.

[0230] To align the specimen 106 in the defined geometry, the foot is placed on the base plate 101 of the device 100 and secured with an adapter 17 under the impact punch 111. The adapter 17 is modeled after an inverted vise. This means that it applies a parallel clamping force from two sides (lateral and medial) to the selected specimen 106. This securely fixes the specimen 106. The adapter 17 is screwed to the impact punch 111. The impulse is thus transmitted directly to the specimen 106. The adapter 17 has a shaft joint, which can be used to adjust the surface that presses on the femur. This allows the force application point in the joint to be controlled in a fracture-specific manner. The knee angle should be between 90 degrees and 105 degrees. The knee joint should be positioned in the transverse plane 2 - 4 cm in front of the ankle joint, the dorsal extension of the foot should be between 0 degrees and 10 degrees.Tibial rotation should not be affected. Lateral flexion (varus / valgus) should not exceed 0 to 5 degrees of valgus.

[0231] The following settings are made on the device 100: The defined mass (fall mass) is 26 to 31 kg, the defined speed is set by means of the fall height to 96 to 12112 cm, the defined compression is set to 35 to 47 mm, and the defined damping is set by the damped portion of the defined compression to 10 to 13 mm. The holding mechanism 114 is triggered, and the tibial plateau fracture of classification 41 B1 according to AO is created in the specimen 106 with a probability of 72%.

[0232] Example 22: Alignment in a defined geometry for the reproducible creation of a talus fracture (type II, type III according to Hawkins).

[0233] For a talus fracture type II, type III according to Hawkins, a specimen 106 consisting of foot and lower leg is clamped.

[0234] To align the specimen 106 in the defined geometry, the lower leg is set approximately 15-20 cm distal to the tibial head. At the proximal end of the lower leg stump, approximately 5 cm of the soft tissue around the tibia and fibula is removed, and the bones are cast vertically in a mold 105 using cold-curing polymer. The mold 105 is connected to the clamping plate 107 on the impact punch 111 in the device 100 according to the invention. The cut surfaces of the tibia and fibula are centrally located below the force application point. The ball of the foot is stably placed on an adapter 03 and held in place using tensioning straps; the plantar flexion of the foot should be 10 to 15 degrees. Lateral tilting (inversion and eversion) should not be influenced. The ankle joint should be 1-3 cm in front of the casting point in the transverse plane.

[0235] The following settings are made on the device 100: The defined mass (fall mass) is 24.8 to 37.2 kg, the defined speed is set by means of the fall height to 68 to 83 cm, the defined compression is set to 26 to 48 mm, and the defined damping is set by means of the damped portion of the defined compression to 0 to 22 mm. The holding mechanism 114 is triggered, and the talus fracture of the Hawkins classification Type II, Type III is created in the specimen 106.

[0236] Example 23: Alignment in a defined geometry for the reproducible creation of a pilon fracture (43 B3 - B4, C1 - C3 according to AO).

[0237] For a pilon fracture 43 B3 - B4, C1 - C3 according to AO, a specimen 106 consisting of foot and lower leg is clamped.

[0238] To align the specimen 106 in the defined geometry, the lower leg is set approximately 15-20 cm distal to the tibial head. At the proximal end of the lower leg stump, approximately 5 cm of the soft tissue around the tibia and fibula is removed, and the bones are cast vertically in a mold 105 using cold-curing polymer. The mold 105 is connected in the device 100 to means for fixing the specimen 102, for example, an adjustable slide on the base plate 101. The cut surfaces of the tibia and fibula are positioned centrally below the force application point. The foot thus stands flat with the sole facing upwards against the clamping plate 107 under the impact punch 111. The ankle joint should be positioned above the casting point in the transverse plane, and the dorsal extension of the foot should not exceed 5 degrees.

[0239] The following settings are made on the device 100: The defined mass (falling mass) is 24.7 to 38.5 kg, the defined speed is set by means of the fall height to 100 to 111 cm, the defined compression is set to 30 to 51 mm, and the defined damping is set by the damped portion of the defined compression to 0 to 25 mm. The holding mechanism 114 is triggered, and the pilon fracture of classification 43 B3-B4, C1-C3 according to AO is created in the specimen 106 with a probability of 62%.

[0240] Example 24: Alignment in a defined geometry for the reproducible creation of a calcaneus fracture (type 2A, 2C, type 3AB, 3AC according to Sanders).

[0241] For a calcaneus fracture type 2A, 2C, type 3AB, 3AC according to Sanders, a specimen 106 consisting of foot and lower leg is clamped.

[0242] To align the specimen 106 in the defined geometry, the lower leg is set approximately 15–20 cm distal to the tibial head. At the proximal end of the lower leg stump, approximately 5 cm of the soft tissue around the tibia and fibula is removed, and the bones are cast vertically in a mold 105 using cold-curing polymer. The mold 105 is connected to the clamping plate 107 on the impact punch 111 in the device 100 according to the invention. The cut surfaces of the tibia and fibula are centrally located below the force application point. The ankle joint should therefore be located below the casting point in the transverse plane. The calcaneus is placed securely on an adapter 03, and the plantar flexion of the foot should not exceed 10 degrees.

[0243] The following settings are made on the device 100: The defined mass (falling mass) is 24.1 to 32.7 kg, the defined speed is set by means of the fall height to 90 to 98 cm, the defined compression is set to 25 to 43 mm, and the defined damping is set by means of the damped portion of the defined compression to 0 to 18 mm. The holding mechanism 114 is triggered, and the calcaneus fracture of the Sanders classification type 2A, 2C, type 3AB, 3AC is created in the specimen 106 with a probability of 61%.

[0244] Example 25: Example procedure for creating a new defined bone fracture in a specimen 106

[0245] Assuming that the newly defined bone fracture is caused by a bicycle accident in which a person with a height of 165 cm and a body weight of 50 kg falls forward onto the road with their arms or hands outstretched, the following initial situation prevails: The fall height is 155 cm and the initial speed is 15 km / h. Etotal=Ekin+Epot(1)=m2v2+m⋅g⋅h(2)=50kg2⋅(4.16ms)2+50kg⋅9.81ms2⋅1.55m(3)=1194J(4)

[0246] The cyclist therefore has just under 1.2 kilojoules of energy before she hits the ground.

[0247] This example shows the dimensions of the initial model calculations. These are based on examples of real-life bicycle accidents. By using different masses for the victims and different speeds upon impact of the victims when falling from the bicycle, an energy range is obtained that is suitable for generating the bone fracture typical in a bicycle accident (= selected, defined bone fracture with accompanying soft tissue injuries). This defined bone fracture, which is typical in a bicycle accident when falling over the handlebars, can be classified, for example, according to the AO Trauma Classification. With the help of the known model calculations, the calculated energy upon impact in the real accident and the biochemical parameters of the victim, e.g.the joint position in the arm or hand of the accident victim upon impact with the road, the parameters, namely the defined mass, the defined direction, the defined speed of the calculated defined mass upon impact, the defined geometry of the specimen 106 in relation to the calculated force impulse upon impact, the defined compression of the specimen 106, the defined damping upon impact of the defined mass.

[0248] The angle adjustments of the joints are performed using a goniometer and documented in all simulations. The varus / valgus adjustments / preloads can also be performed using tensioning straps.

[0249] Example 26: Validation of the defined parameters

[0250] The specimen 106 is clamped in the defined geometry in the fixture 100, 500, and the settings (defined mass, defined speed as a defined height of the falling mass, defined compression, and defined damping) are made on the fixture 100, 500. The force transmitted to the specimens by the impulse during the force impact is measured by the three force measuring rings (type 9011A Kistler, Winterthur, Switzerland) or force sensors installed in the impact punch. To fulfill the above-mentioned sampling theorem and to obtain sufficient measured values ​​over the short duration of the force impact, the signal from the force measuring rings was recorded at 100,000 Hz in the tests with the prototype. The force sensors were arranged in the transverse plane as an equilateral triangle. Based on this arrangement and the individually output force values ​​of the three sensors, the force vector can be subsequently determined from the direction vectors and thus the force application point.The force vector was to run axially (in the z-direction) through specimen 106. Another force sensor (Type 9061A, Kistler, Winterthur, Switzerland) was installed below the clamped specimen and also sampled at 100,000 Hz. The difference between the two force signals allows the energy absorbed by the biological tissue to be estimated.

[0251] Three high-speed cameras 528 (type HCC 1000 (F) BGE, Vosskühler, Allied Vision Technologies GmbH, Stadtroda) are used to optically capture the sequence of injuries. The camera image section is variable but is usually set to 1024 x 256 pixels to achieve the highest possible recording rate of 1825 fps (frames per second). Due to the rapid force application, the recorded data sets result in 15 to 20 images per specimen 106 and camera for evaluation. In all experiments, the cameras are optimally aligned to the markings applied to the specimen 106 and positioned at approximately 120-degree intervals around the specimen 106 ( Fig. 5). Before and after the practical experiments, a calibration is performed for all cameras. This calibration serves as a scaling of the length ratios of the recorded specimens in the subsequent image analysis.

Claims

[1] Method for producing a defined bone fracture with accompanying soft tissue injuries in a preparation (106) comprising bone and soft tissue mantle, wherein the soft tissue mantle is understood to mean all the body's own tissue surrounding the bone of a preparation (106), including muscles, ligaments, tendons, joint capsules, nerves, skin and vessels, wherein a device (100), (200) is used to carry out the method, which i. at least one guide column (118), (218), ii. at one end of the guide column (118), (218) a base plate (101), (201), iii. a crossbeam (109), (209) with stamp (111), (211), iv. at least one means (110), (210) for adjusting the damping upon impact of a defined mass, v. at least one clamping plate (107), (207) for fixing the specimen, vi. a mass (112), (212) and, if necessary, additional weight (113), (213) for setting the defined mass, vii. at least one further cross member (115), (215) with at least one releasable holding mechanism (114), (214) for positioning the defined mass and means for fixing the preparation (102), wherein shock absorbers are used as means for adjusting the damping on impact, characterized by that a defined force impulse is exerted on a fixed specimen (106) and the change in the length of the specimen (106) along the force vector is limited to a maximum of 80 mm by setting a defined compression and a defined damping by means of a shock absorber, wherein a) the defined bone fracture is a pilon fracture, b) a preparation (106) comprising or consisting of foot and lower leg is selected, c) a defined mass of 24.7 to 38.5 kg is set, d) the preparation (106) is aligned in a defined geometry with respect to the direction from which the defined mass impacts the preparation (106) when the holding mechanism (114), (214) is triggered, by means of means for fixing the preparation (102), e) the defined speed is set to 100 to 111 cm by means of the fall height of the defined mass, f) the defined compression is set to 30 to 51 mm with at least one shock absorber, g) the defined damping is set as the damped part of the defined compression to 0 to 25 mm, h) the holding mechanism (114), (214) is triggered, i) the preparation (106) is removed from the device (100), (200). [2] Preparation (106) obtainable by a method according to claim 1 comprising or consisting of foot and lower leg, bone and soft tissue mantle characterized bythat the specimen (106) includes a pilon fracture with accompanying soft tissue injuries.

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