Osteotomy support jigs and digital templates

Abstract

This invention provides an osteotomy support clamp, a digital template, and a long bone correction osteotomy technique that are also applicable to OWHTO surgery and enable accurate intraoperative reproduction of the osteotomy alignment set in the preoperative plan. The osteotomy support clamp includes: a first registration member having a positioning plate as a configuration reference for setting the fixation position of the distal bolt; and a second registration member rotatably connected to the first registration member at any rotation angle about a rotation axis set on the osteotomy line as the cutting reference, for setting the fixation position of the proximal bolt. The fixation positions of the distal and proximal bolts are positioned by the position of the first registration member, the connection position of the second registration member relative to the first registration member, and the connection angle.

Description

Osteotomy support jigs, digital templates, and long bone correction osteotomy This invention relates to an osteotomy support fixture, a digital template, and an osteotomy technique for long bone correction. Osteoarthritis of the knee, a painful condition caused by wear and tear of the knee cartilage, overwhelmingly involves wear and tear of the medial cartilage. One contributing factor is bowlegs (or knock-knees). In bowlegs, the medial side of the knee bears a greater load, making it prone to wear and tear. If only the medial cartilage wears down, the bowlegs will worsen, creating a vicious cycle that exacerbates the disease. One treatment for this type of osteoarthritis of the knee is high tibial osteotomy (HTO). Previously, various osteotomy clamps (e.g., Patent Document 1) were proposed to ensure that high tibial osteotomy was performed according to preoperative planning. High tibial osteotomy refers to a surgical procedure that corrects bowlegs (O-shaped legs) by removing the proximal end of the tibia near the knee, one of the two bones in the lower leg that bears most of the load. This distributes the load from the medial side to the lateral side, reducing the burden and thus alleviating pain and inhibiting the progression of the condition. Osteotomies like high tibial osteotomy are not limited to tibial correction; they are also suitable for correcting long bones such as the femur. [Prior Art Literature] [Patent Literature] [Patent Document 1] Japanese Patent No. 6941393 [The problem that the invention aims to solve] According to the osteotomy support clamp disclosed in Patent Document 1, the osteotomy alignment set in the preoperative plan can be accurately reproduced during the operation of lateral wedge closed high tibial osteotomy (hereinafter referred to as "CWHTO"). However, the osteotomy support clamp disclosed in Patent Document 1 is not applicable to medial wedge expanded high tibial osteotomy (hereinafter referred to as "OWHTO"). As a high tibial osteotomy, OWHTO is more common than CWHTO, and the practical application of clamps applicable to OWHTO is anticipated. The purpose of this invention is to provide an osteotomy support fixture, digital template, and long bone correction osteotomy technique that is also applicable to OWHTO surgery and enables accurate intraoperative reproduction of the osteotomy alignment set in the preoperative plan. [Means for Solving the Problem] The osteotomy support clamp of the present invention is used for positioning distal and proximal bolts for fixing a fixation plate to a long bone after osteotomy. The osteotomy support clamp includes: a first registration member having a positioning plate as a configuration reference for setting the fixation position of the distal bolts; and a second registration member rotatably connected to the first registration member at any rotation angle about a rotation axis set on the osteotomy line as the cutting reference for setting the fixation position of the proximal bolts. The fixation positions of the distal and proximal bolts are positioned by the position of the first registration member, the connection position of the second registration member relative to the first registration member, and the connection angle. The digital template of this invention models the osteotomy support clamp from a side view. The digital template is drawn by including the following information: registration information indicating the position and orientation of the osteotomy support clamp; osteotomy surface information indicating the osteotomy surface associated with the osteotomy support clamp; candidate position information for the rotation axis; fixation position information for the distal bolt; and fixation position information for the proximal bolt. [Effects of the Invention] According to the present invention, not only in CWHTO, but also in OWHTO, the osteotomy alignment set in the preoperative plan can be accurately reproduced during the operation. Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings. In this embodiment, a high tibial osteotomy support clamp 1 (hereinafter referred to as "HTO support clamp 1") using the osteotomy support clamp of the present invention will be described. In this instruction manual, the anatomical orientation is used as a reference, and the directions of vertical, horizontal, and anterior-posterior are used. Furthermore, in the horizontal direction, the side closer to the center is called "medial," and the side farther from the center is called "lateral." In the vertical direction, the side closer to the trunk is called "proximal," and the side farther from the trunk is called "distal." Moreover, regarding the constituent elements of the HTO support clamp 1, the directions of vertical, horizontal, and anterior-posterior are used as a reference, with the HTO support clamp 1 positioned at the osteotomy site. Figures 1A and 1B are diagrams showing the fixation plate 5 fixed to the osteotomy site of the tibia T. Figure 1A shows the state in which the fixation plate 5 is positioned at the osteotomy site, and Figure 1B is a plan view of the fixation plate 5. As shown in Figures 1A and 1B, a metal fixation plate 5 is disposed at the osteotomy site of the tibia T1, such that a distal bone fragment T1 on the lower side (away from the knee) of the osteotomy site is crosslinked with a proximal bone fragment T2 on the upper side (closer to the knee). The fixation plate 5 has bolt holes 51a to 51h through which bolts 52a to 52h are inserted. The distal portion of the fixation plate 5 is fastened to the distal bone fragment T1 by distal bolts 52a to 52d, and the proximal portion of the fixation plate 5 is fastened to the proximal bone fragment T2 by proximal bolts 52e to 52h, thereby fixing the fixation plate 5 to the osteotomy site of the tibia T1. Generally, in CWHTO, an instrument (such as the osteotomy support clamp disclosed in Patent Document 1) is placed against the lateral side of the tibia to remove a wedge-shaped bone fragment that is wider on the lateral side and narrower on the medial side, thereby closing (sealing) the proximal osteotomy surface and the distal osteotomy surface to perform correction. In contrast, in the OWHTO procedure, as shown in Figure 1A, the instrument is placed against the medial side of the tibia T, and osteotomy is performed with one osteotomy surface. The distal bone fragment T1 or the proximal bone fragment T2 is rotated by a predetermined correction angle θ with the hinge axis H, which serves as the axis of rotation during correction, as the center. This expands the gap between the proximal and distal osteotomy surfaces, thereby performing correction. In this embodiment, a template R (see Figure 5) containing information indicating the position and orientation of the HTO support clamp 1 and information indicating the osteotomy alignment associated with the HTO support clamp 1 is used to create a preoperative plan, and the HTO support clamp 1 is used during the operation, thereby enabling the osteotomy alignment set in the preoperative plan to be accurately reproduced during the operation. Here, osteotomy alignment is the information required in osteotomy, including the hinge axis H which serves as the axis of rotation during correction, the target osteotomy surface S (see Figure 2), and the distal bolt fixation position P1 and proximal bolt fixation position P2 of the fixation plate 5 (see Figure 1A, etc.) (see Figure 8), etc. Figure 2 is an example of how the hinge axis H, correction angle θ, and osteotomy surface S are set in the preoperative planning. In preoperative planning, as shown in Figure 2, an IMG image of the entire standing lower limb viewed from the anterior surface (frontal view) is used to draw the actual functional axis ML1 and the ideal target functional axis ML2 before correction, connecting the femoral bone center A and the foot joint (talus) center B1. The target functional axis ML2 is drawn, for example, by rotating the actual functional axis ML1 about the femoral bone center A as a pivot point, so that it passes through a point F (e.g., the lateral edge of the lateral protuberance) approximately 60%–65% of the distance from the medial edge to the lateral edge of the tibial articular surface, where the distance from the medial edge to the lateral edge is set to 100%. As shown in Figure 2, in the case of genu valgum (bowlegs), the actual functional axis ML1 is located medially to the target functional axis ML2. Furthermore, within a safe zone extending from the top of the fibular head to the tibiofibular joint, a hinge axis H is positioned approximately 5 mm medially from the nearest point to the tibiofibular joint. The angle θ formed by the straight line H-B1 connecting the hinge axis H to the pre-correction foot joint center B1 and the straight line H-B2 connecting the hinge axis H to the post-correction foot joint center B2 is the correction angle. Moreover, at the medial end of the tibia T, for example, a position approximately 35 mm to 40 mm distal to the articular surface, an osteotomy starting point E is established. The line connecting the hinge axis H and the osteotomy starting point E is called the osteotomy line. The osteotomy line serves as a cutting reference line; by cutting along the osteotomy line, an osteotomy surface S is formed. That is, the osteotomy surface S is a plane encompassing the osteotomy line. When using the HTO support clamp 1 of this embodiment, the osteotomy surface S (osteotomy line) is associated with the HTO support clamp 1. In the preoperative planning, after the hinge axis H is determined by the surgeon, the template R (see Figure 5) on which the HTO support clamp 1 is drawn is aligned to the optimal position with the hinge axis H as a reference, thereby automatically setting the osteotomy surface S. For example, when using digital X-ray images and digital templates for preoperative planning, as long as the femoral head contour points (three points), the medial and lateral tibial border points (two points in total), and the medial and lateral foot joint border points (two points in total) are digitized, the computer can calculate the three points—the femoral head center A, the target functional axis passing point F, and the pre-correction foot joint center B1—based on the digitized feature points. This allows for the automatic calculation of the actual functional axis ML1, the target functional axis ML2, and the post-correction foot joint center B2. Furthermore, when the hinge axis H is manually set and the template R is positioned optimally, the osteotomy surface S is automatically set. Moreover, the correction angle θ is automatically calculated based on the hinge axis H and the foot joint centers B1 and B2 before and after correction. Figure 3 is a perspective view of the HTO support clamp 1 according to the embodiment. Figure 4A is a plan view of the HTO support clamp 1 viewed from the front, and Figure 4B is a plan view of the HTO support clamp 1 viewed from the left. Furthermore, the HTO support clamp 1 is schematically shown in Figures 3, 4A, and 4B, and the detailed structure of the HTO support clamp 1 is not limited to the structure shown in Figures 3, 4A, and 4B. The HTO support clamp 1 shown in Figure 3 is used in an OWHTO procedure targeting the right tibia. The HTO support clamp used in an OWHTO procedure targeting the left tibia has a symmetrical structure about the sagittal plane perpendicular to the left-right direction. The HTO support clamp 1 is designed to allow for setting of the hinge axis H, osteotomy surface S, distal bolt fixation position P1, and proximal bolt fixation position P2 as defined in the preoperative plan. In the presence of multiple fixation plates 5 with different shapes or bolt fixation positions, the HTO support clamp 1 is prepared for each type of fixation plate 5. Specifically, the osteotomy surface S, distal bolt fixation position P1, and proximal bolt fixation position P2 in the aforementioned osteotomy alignment are pre-set in association with the HTO support clamp 1. Furthermore, the hinge axis H in the HTO support clamp 1 can be selected from multiple hinge candidates. Moreover, the proximal bolt fixation position P2 can be appropriately adjusted based on the correction angle θ set in the preoperative plan. As shown in Figure 3, the HTO support clamp 1 includes a first registration member 10, a second registration member 20, a hinge shaft member 30, a connecting member 40, and a reference antenna 50. Furthermore, the reference antenna 50 is omitted from the illustration in Figure 3. The components constituting the HTO support clamp 1 are formed of, for example, metallic materials such as titanium. The first registration member 10 is a component used for positioning the HTO support clamp 1 relative to the tibia T and setting the osteotomy surface S and the distal bolt fixing position P1. The first registration member 10 has a positioning plate 11, an osteotomy guide 12, a first hinge setting plate 13, and a distal bolt guide 14. The positioning plate 11 serves as the configuration reference for the HTO support clamp 1. During the operation, it abuts against the medial side of the tibia to position the HTO support clamp. The surface of the positioning plate 11 that abuts against the medial side of the tibia has the ability to maintain the shape of the HTO support clamp 1 in a stable posture when it is placed on the tibial T. The osteotomy guide section 12 is used to set the osteotomy surface S and has a cylindrical shape extending along the osteotomy direction. In this embodiment, three osteotomy guide sections 12 are arranged at the proximal end of the positioning plate 11. The osteotomy guide pin 61 (so-called Kirschner wire, see Figure 11) is inserted into the distal bone fragment T1 of the tibia T via the osteotomy guide section 12. Furthermore, multiple osteotomy guide sections 12 can be provided in such a way that the osteotomy surface S is determined by the guide pin 61 inserted through the osteotomy guide section 12. The first hinge setting plate 13 is a plate-shaped member having a main surface orthogonal to the front-back direction (the main surface extends in the up-down and left-right directions). The first hinge setting plate 13 is connected to the positioning plate 11 by a connecting arm 16 extending in the front-back direction. The first hinge setting plate 13 has a plurality of first hinge candidate holes 15 extending in the front-rear direction. The plurality of first hinge candidate holes 15 are arranged on the same straight line as the guiding direction indicated by the osteotomy guide 12. The guiding direction indicated by the osteotomy guide 12 is nothing more than the extension direction of the osteotomy line. That is, when the HTO support clamp 1 is viewed from the front, the first hinge candidate holes 15 are located on the extension line of the osteotomy guide 12, i.e., the osteotomy line. The inner diameter of the first hinge candidate holes 15 is, for example, 1.5 mm to 2.0 mm. In FIG3, etc., the first hinge setting plate 13 extends along the arrangement direction of the first hinge candidate holes 15, but the planar shape of the first hinge setting plate 13 viewed from the front-rear direction is not particularly limited. The distal bolt guide 14 is used to set the distal bolt fixing position P1 of the fixation plate 5 for the distal bone fragment T1 divided by osteotomy. In this embodiment, the distal bolt guide 14 includes three holes provided in the positioning plate 11. The distal bolt guide 14 is provided corresponding to the distal bolt holes 51a to 51c of the fixation plate 5 (see Figure 1B). Furthermore, the distal bolt guide 14 may be provided corresponding to two or all four of the four distal bolt holes 51a to 51d of the fixing plate 5. That is, multiple distal bolt guides 14 may be provided in such a way that the fixing position of the distal part of the fixing plate 5 is determined by the guide pin 62 (see Figure 11) for the distal bolt inserted through the distal bolt guide 14. The second registration member 20 is a component used to set the proximal bolt fixation position P2 of the proximal bone fragment T2. The second registration member 20 has a second hinge setting plate 21 and a proximal bolt guide part 22. The second hinge setting plate 21 is a plate-shaped member having a main surface (a main surface extending in the vertical and horizontal directions) orthogonal to the front-back direction, similar to the first hinge setting plate 13. The second hinge setting plate 21 is connected to the proximal bolt guide portion 22 by a connecting arm 24 extending in the front-back direction. The second hinge setting plate 21 has a plurality of second hinge candidate holes 23 extending in the front-rear direction. The plurality of second hinge candidate holes 23 are arranged in a straight line in a manner corresponding to the first hinge candidate holes 15 provided on the first hinge setting plate 13. The inner diameter of the second hinge candidate holes 23 is, for example, 1.5 mm to 2.0 mm. Similar to the first hinge setting plate 13, the planar shape of the second hinge setting plate 21 viewed from the front-rear direction is not particularly limited. The proximal bolt guide section 22 is used to set the proximal bolt fixing position P2 of the fixation plate 5 on the proximal bone fragment T2 divided by osteotomy. In this embodiment, the proximal bolt guide section 22 includes two guide tubes. The proximal bolt guide section 22 is provided corresponding to the proximal bolt holes 51f and 51h of the fixation plate 5 (see Figure 1B). Furthermore, the proximal bolt guide 22 can also be provided corresponding to all three of the three distal bolt holes 51a to 51c of the fixing plate 5. That is, multiple proximal bolt guides 22 can be provided in such a way that the fixing position of the proximal part of the fixing plate 5 is determined by the guide pin 63 (see Figure 11) for the proximal bolt inserted through the proximal bolt guide 22. The first registration member 10 and the second registration member 20 are arranged such that the portion of the first hinge setting plate 13 with the first hinge candidate hole 15 and the portion of the second hinge setting plate 21 with the second hinge candidate hole 23 overlap in the front-to-back direction, and are connected by the hinge shaft member 30 and the connecting member 40. The hinge axis member 30 connects the first registration member 10 and the second registration member 20 in the anterior-posterior direction, and rotatably supports the second registration member 20 in the coronal plane relative to the first registration member 10. The hinge axis member 30 is configured to freely insert and detach from the first hinge candidate hole 15 of the first registration member 10 and the second hinge candidate hole 23 of the second registration member 20. The combination of the first hinge candidate hole 15 and the second hinge candidate hole 23 through which the hinge axis member 30 is inserted is selected according to the preoperative plan. That is, the rotation axis including the hinge axis member 30 is variable along the arrangement direction of the first hinge candidate hole 15, i.e., the osteotomy line. The connecting member 40 is a component used to connect the first registration member 10 and the second registration member 20 and fix their relative postures. Furthermore, the connecting member 40 functions as a posture adjustment part, allowing the second registration member 20 to rotate relative to the first registration member 10 with the hinge axis member 30 as a fulcrum, thereby changing their relative postures. Moreover, the HTO support clamp 1 may also include a posture adjustment part independently of the connecting member 40. The connecting member 40 is configured to extend and retract in length, and with extension and retraction, both ends rotate relative to the first hinge setting plate 13 and the second hinge setting plate 21. Furthermore, the connecting member 40 can fix the length of the connection. Furthermore, the connecting member 40 is provided with a scale 41 indicating the connection length, and the rotation angle of the second hinge setting plate 21 relative to the first hinge setting plate 13 with the hinge axis member 30 as the fulcrum is associated with the scale 41. That is, the rotation angle of the second hinge setting plate 21 relative to the first hinge setting plate 13 with the hinge axis member 30 as the fulcrum can be identified based on the position of the hinge axis member 30 and the connection length. Furthermore, the HTO support fixture 1 may also include an angle detection unit such as an angle sensor that automatically detects the rotation angle of the second registration member 20 relative to the first registration member 10 (illustration omitted). The reference antenna 50 is, for example, a rod-shaped member extending in a generally vertical direction, and is mounted on the upper surface of the first hinge setting plate 13. The reference antenna 50 is used to define the vertical position of the HTO support clamp 1 relative to the tibia T. The vertical position of the HTO support clamp 1 is determined by aligning the proximal front end 51 of the reference antenna 50 with the reference plane of the osteotomy (e.g., the proximal lateral articular surface of the tibia). The reference antenna 50 is, for example, telescopically adjustable, allowing for adjustment of the position of its front end 51. That is, the reference antenna 50 is configured such that the vertical position of the HTO support clamp 1, determined by the length of the reference antenna 50, is variable. This facilitates adjustments to the position of the fixation plate 5, i.e., the vertical position of the HTO support clamp 1, during preoperative planning, enabling the HTO support clamp 1 to be positioned on the tibia according to the preoperative plan. In the initial state of the HTO support clamp 1, the first hinge candidate hole 15 and the second hinge candidate hole 23 are aligned in the front-to-back direction. The term "initial state" refers to the state in which the distal bolt guide part 14 and the proximal bolt guide part 22 correspond to the distal bolt hole and proximal bolt hole of the fixing plate 5, respectively. The rotation angle of the second hinge setting plate 21 relative to the first hinge setting plate 13 is expressed based on the initial state (rotation angle 0°). The following describes the preparation of the preoperative plan and the actual procedure for OWHTO using the HTO support clamp 1. In this embodiment, an example of preoperative planning using 2D images will be described. In preoperative planning, a template R as shown in Figure 5 is used. For example, when preoperative planning is performed by drawing a diagram analogous to X-ray film, a film-shaped template is used. Furthermore, for example, when preoperative planning is performed by computer calculation using digital X-ray images, a digital template is used. On template R, registration information I1 indicating the position and orientation of HTO support clamp 1, osteotomy surface information I2 indicating the osteotomy surface defined by HTO support clamp 1, and hinge candidate information I3 indicating hinge candidates are drawn. Furthermore, on template R, distal bolt information I4 indicating the distal bolt fixation position P1 and proximal bolt information I5 indicating the proximal bolt fixation position P2 (insertion direction) are drawn. Each piece of information is drawn in a form that allows for understanding the positional relationship with the tibia T and is easily visually identifiable. In the case of a digital template, each piece of information has two-dimensional coordinate data. In Figure 5, registration information I1 is represented by an image modeling the state of the HTO support clamp 1 as viewed from the front. Osteotomy surface information I2, distal bolt information I4, and proximal bolt information I5 are each represented by a single-point chain. Furthermore, hinge candidate information I3 is represented by a circular image. Moreover, the display form of registration information I1 is not limited to that shown in Figure 5. That is, it is sufficient as long as it includes at least information representing the tibial abutment surface of the positioning plate 11 to determine the setting position of the HTO support clamp 1 relative to the tibia T. Osteotomy surface information I2, hinge candidate information I3, distal bolt information I4, and proximal bolt information I5 are associated with registration information I1. That is, when the position or orientation of registration information I1 changes, the corresponding positions or orientations of osteotomy surface information I2, hinge candidate information I3, distal bolt information I4, and proximal bolt information I5 also change. Moreover, proximal bolt information I5 can rotate around hinge candidate information I3 (the hinge axis H set in the preoperative planning). The preoperative planning in this embodiment will now be described with reference to Figures 6 to 9. Furthermore, the osteotomy site is shown in enlarged form in Figures 6 to 9. In the preoperative planning, as illustrated in Figure 2, for example, on a standing X-ray image of the entire lower limb, the femoral head contour points (three points), the medial and lateral tibial border points (two points in total), and the medial and lateral foot joint border points (two points in total) are digitized. Using computer calculations based on these digitized feature points, the femoral head center A, the target functional axis passing through point F, and the pre-correction foot joint center B1 are determined. This automatically calculates the actual functional axis ML1, the target functional axis ML2, and the post-correction foot joint center B2. Furthermore, when the hinge axis H is manually set, the correction angle θ is automatically calculated based on the hinge axis H and the foot joint centers B1 and B2 before and after correction. Subsequently, as shown in Figure 6, when the template R is positioned in the optimal position, the osteotomy surface S is automatically determined. Specifically, the template R of the HTO support clamp 1 is aligned with the X-ray image. While referring to the registration information I1 and the hinge candidate information I3, the position and orientation of the template R are adjusted so that the positioning plate 11 fits the medial cortex of the tibia, and the set hinge axis H is consistent with any one of the multiple hinge candidate holes. In Figure 6, the second hinge candidate hole from the right is consistent with the set hinge axis H. At this point, as shown in Figure 7, the osteotomy surface S and the distal bolt fixation position P1 are temporarily determined. Subsequently, as shown in Figure 8, the alignment of the lower limb after correction and the suitability of the shape of the fixation plate 5 are confirmed. Specifically, the proximal bone fragment image I6, taken at the temporarily determined osteotomy surface S, is displayed in a state where the hinge axis H has been rotated by a correction angle θ. Furthermore, the model image I7 of the fixation plate 5 is overlaid based on the registration information I1. In cases of extremely poor shape fit, it is necessary to change to another type of fixation plate with a different size or shape. Therefore, the preoperative planning for using the HTO support clamp 1 with the fixation plate must be redone. By establishing a preoperative plan that includes the shape of the fixation plate 5 and the shape fit of the corrected plate placement area, it is possible to prevent situations where it is determined during the operation that the shape of the fixation plate 5 is unsuitable, thus destroying the correction angle θ after the fixation plate 5 has been set up. Furthermore, if the deviation from the shape fit is small, the hinge axis H can be reset. Moreover, it is preferable that the fit of the corrected bone shape to the fixation plate 5 is determined not only in the frontal image viewed from the front-back direction shown in Figure 8, but also in the side image viewed from the left-right direction. Subsequently, as shown in Figure 9, reference antenna information I8 is added to template R to quantitatively determine the proximal and distal positions (vertical positions) of the HTO support clamp 1 during surgery. Reference antenna information I8 indicates the extension direction of reference antenna 50. For example, by digitizing the intersection point of the proximal lateral tibial articular surface and reference antenna information I8, this point is set as the position of the anterior end portion 50a of reference antenna 50, and the length of reference antenna 50 is automatically calculated. This is how preoperative planning for OWHTO surgery using HTO support clamp 1 is created. Figures 10 to 14 illustrate the OWHTO procedure according to the aforementioned preoperative plan. The OWHTO procedure is performed while confirming the preoperative plan under X-ray fluoroscopy. As shown in Figure 10, during the OWHTO procedure, as a preparatory step, the HTO support clamp 1 is set up according to the preoperative plan. Specifically, the length of the reference antenna 50 is adjusted according to the preoperative plan. The hinge shaft member 30 is inserted into the hinge candidate hole selected in the preoperative plan and fixed in place without detachment. Furthermore, the connection length of the connecting member 40 is adjusted so that the second registration member 20 (second hinge setting plate 21) rotates relative to the first registration member 10 (first hinge setting plate 13) by the correction angle θ set in the preoperative plan. Alternatively, after setting the HTO support clamp 1 in its initial state at the optimal position of the osteotomy site, the connection length of the connecting member 40 can be adjusted to rotate the second registration member 20 relative to the first registration member 10. Next, as shown in Figure 11, the HTO support clamp 1 is positioned at the designated location on the tibia T. Specifically, while aligning the tibial abutment surface of the positioning plate 11 along the tibial shaft, the anterior end 50a of the reference antenna 50 is aligned with the same level as the proximal lateral articular surface of the tibia. Thus, the position of the HTO support clamp 1 relative to the tibia T is determined. Furthermore, the placement of the HTO support clamp 1 is reproduced according to the preoperative plan, and the HTO support clamp 1 is maintained in a stable posture. Next, the osteotomy alignment is set using the HTO support clamp 1, which is positioned optimally at the osteotomy site. The HTO support clamp 1 is associated with the hinge axis H, osteotomy surface S, distal bolt fixation position P1, and proximal bolt fixation position P2, which are set in the preoperative plan, so the osteotomy alignment can be easily set according to the preoperative plan. Specifically, as shown in Figure 12, guide pins 61 to 63 are inserted into the tibia T. The three osteotomy guide pins 61 are inserted via the osteotomy guide portion 12 of the HTO support clamp 1 and are used as indicators when forming the osteotomy surface S. The guide pin 62 for the distal bolt is inserted via the distal bolt guide portion 14 into the distal bone fragment T1 and is used as an indicator when fixing the distal bolts 52a to 52d. The two proximal bolt guide pins 63 are inserted via the proximal bolt guide portion 22 and are used as indicators when fixing the proximal bolts 52f and 52h. By using the HTO support clamp 1 in this way, the osteotomy surface S, the distal bolt fixation position P1, and the proximal bolt fixation position P2 of the fixation plate 5 can be set in a stable state before osteotomy. Furthermore, by simply rotating the second registration member 20 relative to the first registration member 10, the proximal bolt holes 51f to 51h of the fixation plate 5 will face the direction indicated by the proximal bolt guide 22 after correction (after rotating the distal bone fragment T1 by the correction angle θ). Therefore, not only the distal bolt fixation position P1, but also the proximal bolt fixation position P2 can be easily set. Moreover, since the fixation plate 5 is fixed based on the bolt fixation positions P1 and P2 set before osteotomy, even if mismatch occurs at the osteotomy surface, it can be corrected according to the preoperative plan. Next, as shown in Figure 12, the HTO support clamp 1 is removed, and the osteotomy guide pin 61 is used as an indicator to perform osteotomy from the medial side of the left tibia toward the hinge axis H. Then, as shown in Figure 13, the distal bone fragment T1 is rotated and expanded distally with the hinge axis H as the fulcrum. As a result, the lateral bending angle θ of the tibia T is corrected. Next, as shown in Figure 13, a fixation plate 5 is installed spanning the distal bone fragment T1 and the proximal bone fragment T2, and fixed by distal bolts 52a-52d and proximal bolts 52e-52h. The distal bolts 52a-52d and proximal bolts 52e-52h may include hollow bolts, allowing guide pins 62 and 63 to be inserted while fixing. Furthermore, artificial bone or autologous bone is filled between the osteotomy surfaces of the distal bone fragment T1 and the proximal bone fragment T2. In this embodiment, the distal bolt fixation position P1 and the proximal bolt fixation position P2 are set before the osteotomy, so the fixation plate 5 can be securely fixed in the appropriate position, thereby achieving correction according to the preoperative plan. In an extreme case, even if the osteotomy is not performed accurately according to the preoperative plan, correction according to the preoperative plan can still be achieved by fixing the fixation plate 5 in the appropriate position. Since appropriate correction can be achieved regardless of the surgeon's osteotomy technique, the stability of the corrective osteotomy is improved. The OWHTO procedure is performed in this manner. In this embodiment, the HTO support clamp 1 is associated with the osteotomy alignment set in the preoperative plan. Therefore, by adjusting and setting the HTO support clamp 1 according to the preoperative plan, the osteotomy alignment according to the preoperative plan can be reproduced during the operation. Thus, the HTO support clamp 1 (osteotomy support clamp) of this embodiment is an osteotomy support clamp used for long bone correction osteotomy, including: a first registration member 10, a second registration member 20, a hinge shaft member 30 that rotatably supports the second registration member 20 relative to the first registration member 10, and a connecting member 40 that connects the first registration member 10 and the second registration member 20 and fixes their relative postures. The first registration member 10 has: a positioning plate 11 that abuts against the tibia T (long bone); an osteotomy guide portion 12 for setting the osteotomy surface; a first hinge setting plate 13 having a plurality of first hinge candidate holes 15 arranged in a straight line with the guiding direction of the osteotomy guide portion 12 when viewed from the front-back direction; and a distal bolt guide portion 14 for setting the distal bolt fixing position P1 of the fixing plate 5 for the distal bone fragment T1 of the proximal bone fragment T2 and the distal bone fragment T1 divided by osteotomy. The second registration member 20 includes: a second hinge setting plate 21 having a plurality of second hinge candidate holes 23 corresponding to a plurality of first hinge candidate holes 15; and a proximal bolt guide 22 for setting the proximal bolt fixing position P2 of the proximal bone piece T2 fixing plate 5. The first hinge candidate holes 15 and the second hinge candidate holes 23 are aligned in the front-rear direction in the initial state, and the hinge shaft member 30 is inserted into one of the plurality of groups of first hinge candidate holes 15 and second hinge candidate holes 23. Based on the HTO support clamp 1, the osteotomy alignment is specified by the HTO support clamp 1. Therefore, by using a template modeled with the HTO support clamp 1 for preoperative planning and performing the HTO procedure using the HTO support clamp 1, the osteotomy alignment set in the preoperative plan can be accurately reproduced intraoperatively. Furthermore, in the preoperative planning, a hinge axis H can be selected from multiple hinge candidate holes to be set according to the case, thus enabling OWHTO procedures where the setting of the hinge axis H is crucial. Moreover, the proximal bolt fixation position P2 relative to the proximal bone fragment T2 and the distal bolt fixation position P1 relative to the distal bone fragment T1 can be pre-confirmed in the preoperative planning, including the fixation position of the fixation plate 5, to set an appropriate osteotomy alignment. After the osteotomy, the fixation plate 5 can be securely fixed in the appropriate position, thereby achieving correction according to the preoperative plan. Furthermore, in the HTO support clamp 1, the connecting member 40 functions as a posture adjustment part, that is, it rotates the second registration member 20 relative to the first registration member 10 with the hinge shaft member 30 as the fulcrum, thereby changing the relative posture. Specifically, the connecting member 40 is configured to have a telescopic connection length, which is related to the rotation angle of the second registration member 20 relative to the first registration member 10. As a result, the proximal bolt guide 22 can be easily fixed to a position corresponding to the correction angle θ. Furthermore, the HTO support clamp 1 includes a reference antenna 50, which is disposed on the first registration member 10 and is used to define the vertical position. Moreover, the vertical position defined by the reference antenna 50 is variable. Therefore, adjustments to the position of the fixation plate 5, i.e., the vertical position of the HTO support clamp 1, during preoperative planning can be easily made, allowing the HTO support clamp 1 to be set on the tibia according to the preoperative plan. Furthermore, the HTO support clamp 1 of the embodiments includes, individually or in appropriate combinations, the following features. That is, the HTO support clamp 1 (osteotomy support clamp) is an osteotomy support clamp used for positioning the distal bolts 52a to 52d and the proximal bolts 52e to 52h of the tibia (long bone) after osteotomy to fix the fixation plate 5 to the osteotomy. The HTO support clamp 1 (osteotomy support clamp) includes: a first registration member 10, having a positioning plate 10 as a configuration reference for setting the fixation position P1 of the distal bolts 52e to 52h; and a second registration member. 20. The first registration member 10 is rotatably connected to the second registration member 20 at any rotation angle with the rotation axis (hinge member 30) set on the osteotomy line as the cutting reference. The fixed positions P2 of the proximal bolts 52e to 52h are set. The fixed positions P1 and P2 of the distal bolts 52a to 52d and the proximal bolts 52e to 52h are positioned by the position of the first registration member 10, the connection position of the second registration member 20 relative to the first registration member 10, and the connection angle. In the HTO support clamp 1 (osteotomy support clamp), the hinge shaft component 30 (rotation shaft) is variable along the osteotomy line. The HTO support clamp 1 (osteotomy support clamp) includes a hinge shaft member 30, which rotatably supports a second registration member 20 relative to a first registration member 10. The first registration member 10 has: a first hinge setting plate 13 having a plurality of first hinge candidate holes 15 arranged along the osteotomy line when viewed from the front-back direction; and a distal bolt guide 14 for setting the fixed position P1 of distal bolts 52a to 52d. The second registration member 20 has: a second hinge setting plate 21 having a plurality of second hinge candidate holes 23 corresponding to the plurality of first hinge candidate holes 15; and a proximal bolt guide 22 for setting the fixed position P2 of proximal bolts 52e to 52h. The hinge shaft member 30 is inserted into one of the plurality of groups of first hinge candidate holes 15 and second hinge candidate holes 23. In the HTO support clamp 1 (osteotomy support clamp), the first registration member 10 has an osteotomy guide part 12 that defines the plane containing the osteotomy line, i.e., the osteotomy surface. The osteotomy surface is positioned by the position of the first registration member 10, the connection position and connection angle of the second registration member 20 relative to the first registration member 10, and the positioning of the fixed positions P1 and P2 of the distal bolts 52a to 52d and the proximal bolts 52e to 52h. In the HTO support clamp 1 (osteotomy support clamp), the positioning plate 10 abuts against the diaphysis of the tibia T. Furthermore, the HTO support clamp 1 (osteotomy support clamp) includes a connecting member 40, which connects the first registration member 10 and the second registration member 20 and fixes their relative positions. In the HTO support clamp 1 (osteotomy support clamp), the connecting member 40 functions as a posture adjustment part, that is, it rotates the second registration member 20 relative to the first registration member 10 with the hinge shaft member 30 (rotation shaft) as the fulcrum, so as to change the relative posture. In the HTO support clamp 1 (osteotomy support clamp), the connecting member 40 is configured to extend the connection length, which is related to the rotation angle of the second registration member 20 relative to the first registration member 10. HTO support clamp 1 (osteotomy support clamp) further includes a reference antenna 50, which is disposed on the first registration member 10 for defining the position in the vertical direction. In the HTO support clamp 1 (osteotomy support clamp), the position in the vertical direction, as specified by the reference antenna 50, is variable. The HTO support clamp 1 (osteotomy support clamp) further includes an angle detection unit that detects the rotation angle of the second registration member 20 relative to the first registration member 10 when the second registration member 20 rotates with the hinge axis member 30 (rotation axis) as the fulcrum. The digital template R in this embodiment is a digital template used to model the HTO support clamp 1 (osteotomy support clamp) from a side view. The digital template R is drawn by including the following information: registration information I1, which indicates the position and orientation of the HTO support clamp 1; osteotomy surface information I2, which indicates the osteotomy surface associated with the HTO support clamp 1; hinge axis information I3 (candidate position information of the rotation axis); distal bolt information I4 (fixation position information of distal bolts 52a to 52d); and proximal bolt information I5 (fixation position information of proximal bolts 52e to 52h). The digital template R contains a model image I7 (fixed plate information) of the fixed plate 5 modeled in a side view. In long bone osteotomy using HTO support clamp 1 (osteotomy support clamp), a digital template R is used for preoperative planning. The connection position and angle of the second registration member 20 relative to the first registration member 10 are adjusted according to the preoperative plan. The HTO support clamp 1 (osteotomy support clamp) is then placed at the designated location on the tibia T (long bone) according to the preoperative plan. Before cutting the tibia T, the guide pins 62 and 6 are placed using the HTO support clamp 1. 3. Insert the distal bolts 52a-52d and the proximal bolts 52e-52h into the fixation positions P1 and P2, and perform osteotomy on the tibial T. While rotating the osteotomized tibial T, position the fixation plate 5 with the guide pins 62 and 63 as the target. Insert the distal bolts 52a-52d and the proximal bolts 52e-52h along the guide pins 62 and 63 to fix the fixation plate 5 to the tibial T. The invention described above is based on the embodiments, but the invention is not limited to the embodiments described, and can be modified within the scope without departing from its spirit. For example, the HTO support clamp 1 described in the embodiment includes an osteotomy guide 12 for setting the osteotomy surface S, but it may not include the osteotomy guide 12, or a clamp different from the HTO support clamp 1 may be used to set the osteotomy surface S. Furthermore, in this embodiment, the hinge shaft member 30 is inserted into a set of hinge candidate holes 15 and 23 selected from the plurality of hinge candidate holes 15 provided in the first hinge setting plate 13 and the plurality of hinge candidate holes 23 provided in the second hinge setting plate 21, thereby setting the hinge shaft H. The hinge shaft H is variable along the arrangement direction of the hinge candidate holes 15 and 23, i.e., the osteotomy line, but the setting shape of the hinge shaft H is not limited to this. For example, elliptical openings along the osteotomy line can also be provided in the first hinge setting plate 13 and the second hinge setting plate 21, and the hinge shaft member 30 can be fixed at any position within the opening. Furthermore, for example, in the HTO support clamp 1, the osteotomy guide 12 and the first hinge setting plate 13 can be connected relative to the positioning plate 11 in a multi-stage (e.g., three-stage) manner, changing the guiding direction of the osteotomy guide 12. For example, a rotation axis is provided at the proximal end of the positioning plate 11, allowing the osteotomy guide 12 and the first hinge setting plate to be rotated discretely by a predetermined angle (e.g., 5°) around this rotation axis. In this case, the second hinge setting plate 21 has second hinge candidate holes 23 corresponding to all positions where the first hinge candidate hole 15 can be taken. That is, in the HTO support clamp 1 (osteotomy support clamp), the first hinge setting plate 13 can be connected to the positioning plate 11 in a manner where the osteotomy line can be changed in multiple stages, and the second hinge setting plate 21 has second hinge candidate holes 23 corresponding to all positions where the first hinge candidate hole can be taken. Furthermore, the HTO support clamp 1 (osteotomy support clamp) can also be configured such that at least one of the relative position and relative posture of the distal bolt guide 14 and the first hinge candidate hole 15 (rotation axis) is variable. Specifically, the HTO support clamp 1 (osteotomy support clamp) can also be configured such that at least one of the relative position and relative posture of the positioning plate 11 and the first hinge setting plate 13 (rotation axis setting plate) is variable. More specifically, in the HTO support clamp 1 (osteotomy support clamp), the length of the connecting arm 16 is made variable, thereby allowing the relative position between the positioning plate 11 and the first hinge setting plate 13 to be easily changed. Furthermore, the posture (connection configuration) of the connecting arm 16 relative to the positioning plate 11 or the first hinge setting plate 13 can also be made variable, thereby allowing the relative posture between the positioning plate 11 and the first hinge setting plate 13 to change. Furthermore, in the HTO support clamp 1 (osteotomy support clamp), the connecting arm 16 can be interchangeably configured relative to the positioning plate 11 and the first hinge setting plate 13 (rotation axis setting plate), and can be selected from a number of variations with different lengths. Furthermore, in the HTO support clamp 1 (osteotomy support clamp), the first registration member 10 can be selected from at least one of several variations of the relative position and relative posture of the positioning plate 11 and the first hinge setting plate 13 (rotation axis setting plate). According to the aforementioned variations, the combination of the position of the hinge axis H, the correction angle θ, and the position and size of the fixing plate 5 varies depending on the case, and can be widely used to address various cases. This invention is applicable not only to the OWHTO procedure described in the embodiments, but also to the CWHOT procedure or corrective osteotomy of long bones such as the femur. It should be understood that the embodiments disclosed herein are illustrative in all respects and not limiting. The scope of the invention is defined by the claims rather than by the description herein, and is intended to include the same meaning as the claims and all modifications within that scope. The entire contents of the specification, drawings and abstract contained in Japanese Patent Application No. 2022-007120, filed on January 20, 2022, are incorporated herein by reference. 1: HTO support clamp (osteotomy support clamp) 5: Fixation plate 10: First registration component 11: Positioning plate 12: Osteotomy guide 13: First hinge setting plate 14: Distal bolt guide 15: First hinge candidate hole 16, 24: Connecting arm 20: Second registration component 21: Second hinge setting plate 22: Proximal bolt guide 23: Second hinge candidate hole 30: Hinge shaft component 40: Connecting component 41: Scale 50: Reference antenna 51: Anterior end 52a~52d: Distal bolt 52e~52h: Proximal bolt 61, 62, 63: Guide pin A: Femoral head center B1: Pre-correction foot B2: Corrected foot joint center; E: Osteotomy start point; F: Target functional axis through point; H: Hinge axis; I1: Registration information; I2: Osteotomy surface information; I3: Hinge candidate information; I4: Distal bolt information; I5: Proximal bolt information; I6: Proximal bone fragment image; I7: Model image; I8: Reference antenna information; IMG: X-ray image; ML1: Actual functional axis before correction; ML2: Ideal target functional axis; P1: Distal bolt fixation position; P2: Proximal bolt fixation position; R: Template; S: Osteotomy surface; T: Tibia; T1: Distal bone fragment; T2: Proximal bone fragment; θ: Correction angle. Figures 1A and 1B are diagrams showing the fixation plate fixed to the osteotomy portion of the tibia. Figure 2 is a diagram showing an example of the method for setting the hinge axis H, correction angle θ, and osteotomy surface S in the preoperative planning. Figure 3 is a perspective view of the HTO support clamp according to the embodiment. Figures 4A and 4B are plan views of the HTO support clamp. Figure 5 is a diagram showing an example of the template used in the preoperative planning. Figure 6 is a diagram illustrating the preoperative planning of the embodiment. Figure 7 is a diagram illustrating the preoperative planning of the embodiment. Figure 8 is a diagram illustrating the preoperative planning of the embodiment. Figure 9 is a diagram illustrating the preoperative planning of the embodiment. Figure 10 is a diagram illustrating high tibial osteotomy according to the preoperative plan. Figure 11 is a diagram illustrating high tibial osteotomy according to the preoperative plan. Figure 12 is a diagram illustrating high tibial osteotomy according to the preoperative plan. Figure 13 is a diagram illustrating high tibial osteotomy according to the preoperative plan. Figure 14 is a diagram illustrating high tibial osteotomy according to the preoperative plan. 1: HTO support clamp (osteotomy support clamp) 10: First registration component 11: Positioning plate 12: Osteotomy Guiding Section 13: First hinge setting plate 14: Remote bolt guide 15: First hinge candidate hole 20: Second registration component 21: Second hinge setting plate 22: Proximal bolt guide section 30: Hinge shaft component 40: Connecting structural components 41: Scale 50: Reference Antenna 51: Front end

Claims

1. An osteotomy support clamp for positioning distal and proximal bolts used to fix a fixation plate to the long bone after osteotomy, the osteotomy support clamp comprising: The first registration component has a positioning plate as a configuration reference for setting the fixing position of the distal bolt; The second registration member is rotatably connected to the first registration member at any rotation angle with respect to a rotation axis set on the osteotomy line that serves as the cutting reference. The fixed position of the proximal bolt is set by the position of the first registration member, the connection position of the second registration member relative to the first registration member, and the connection angle. The fixed positions of the distal bolt and the proximal bolt are located by the position of the first registration member, the connection position of the second registration member relative to the first registration member, and the connection angle. The rotation axis is variable along the osteotomy line.

2. The osteotomy support clamp as described in claim 1, comprising: A hinge shaft member rotatably supports a second registration member relative to a first registration member. The first registration member has: a first hinge setting plate having a plurality of first hinge candidate holes arranged along the osteotomy line when viewed from the front-back direction; and a distal bolt guide for setting the fixing position of the distal bolt. The second registration member has: a second hinge setting plate having a plurality of second hinge candidate holes corresponding to the plurality of first hinge candidate holes; and a proximal bolt guide for setting the fixing position of the proximal bolt. The hinge shaft member is inserted into one of the plurality of groups of the first hinge candidate holes and the plurality of groups of the second hinge candidate holes.

3. The osteotomy support clamp as claimed in claim 1, wherein the first registration member has an osteotomy guide portion that defines the plane including the osteotomy line, i.e., the osteotomy surface, and the osteotomy surface is positioned by means of the position of the first registration member, the connection position and connection angle of the second registration member relative to the first registration member, and the positioning of the fixing position of the distal bolt and the proximal bolt.

4. The osteotomy support clamp as claimed in claim 1, wherein the long bone is the tibia, and the positioning plate abuts against the diaphysis of the tibia.

5. The osteotomy support clamp as described in claim 1, comprising: A connecting structural member connects the first registration member and the second registration member, fixing their relative postures.

6. The osteotomy support jig as claimed in claim 5, wherein the connecting member functions as a posture adjustment unit, that is, rotating the second registration member relative to the first registration member about the rotation axis as a fulcrum, so as to change the relative posture.

7. The osteotomy support jig as claimed in claim 6, wherein the connecting member is configured to extend or retract in length, the connecting length being associated with the rotation angle of the second registration member relative to the first registration member.

8. The osteotomy support clamp as described in claim 1, further comprising: A reference antenna, configured on the first registration member, is used to define its position in the vertical direction.

9. The osteotomy support jig as claimed in claim 8, wherein the position in the vertical direction defined by the reference antenna is variable.

10. The osteotomy support clamp as claimed in claim 2, wherein the first hinge setting plate is connected to the positioning plate in a manner that allows the osteotomy line to be changed in multiple stages, and the second hinge setting plate has the second hinge candidate hole corresponding to all possible positions of the first hinge candidate hole.

11. The osteotomy support clamp as described in claim 1, further comprising: The angle detection unit detects the rotation angle of the second registration member relative to the first registration member when the second registration member rotates with the rotation axis as the fulcrum.

12. The osteotomy support clamp as claimed in claim 1, wherein the first registration member has a distal bolt guide for setting the fixed position of the distal bolt, and at least one of the relative position and relative posture of the distal bolt guide to the rotation axis is variable.

13. The osteotomy support clamp as claimed in claim 12, wherein the first registration member has a rotation axis setting plate for setting or fixing the rotation axis, the distal bolt guide is formed on the positioning plate, and at least one of the relative position and the relative posture between the positioning plate and the rotation axis setting plate is variable.

14. The osteotomy support clamp as claimed in claim 13, wherein the first registration member has a connecting arm connecting the positioning plate and the rotation axis setting plate, the length of the connecting arm being variable.

15. The osteotomy support clamp as claimed in claim 14, wherein the connecting arm is interchangeably configured relative to the positioning plate and the rotation axis setting plate, selected from a plurality of variations of different lengths.

16. The osteotomy support clamp as claimed in claim 12, wherein the first registration member has a rotation axis setting plate for setting or fixing the rotation axis, the distal bolt guide is formed on the positioning plate, and the first registration member is selected from at least one of a plurality of variations of the relative position and relative orientation of the positioning plate and the rotation axis setting plate.

17. A digital template for modeling an osteotomy support jig as claimed in claim 1 from a side view, the digital template being drawn by including: registration information indicating the position and orientation of the osteotomy support jig; osteotomy surface information indicating the osteotomy surfaces associated with the osteotomy support jig; candidate position information for the rotation axis; fixation position information for the distal bolt; and fixation position information for the proximal bolt.

18. The digital template as described in claim 17, wherein the digital template includes fixture information for modeling the fixture in a side view.

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