Effective treatment of patellar luxation

Abstract

A method of treating patellar luxation in a patient, the method comprising steps of examining the patient and imaging the affected joint. Comparing the image of the affected joint with the contralater

Description

INTRODUCTION [11 Patellar luxation is widely recognised by veterinary physicians as a hereditary disorder in dogs. This disorder is generally characterised by ectopic development of the patella medial or lateral to the trochlear groove of the femur (thigh bone). Leaving patellar luxation untreated can readily lead to multiple deformities of the hindlimb, involving the hip joint, femur, and tibia. Medial patellar luxation can be involved with a reduced coxofemoral angle (coxa vara), lateral bowing of the femur, internal rotation of the tibia, shallow trochlear groove, and hypoplasia of the medial femoral condyle. [2] Statistical considerations have recognised patellar luxation as the seventh most common orthopaedic disease in dogs such as small breed dogs and cats. Patellar luxation can be classified as congenital, developmental, or traumatic. In most cases, patellar luxation is considered a disease of growth as it develops at an early age. Whether existing congenital musculoskeletal anomalies lead to luxation of the patella or the luxated patella at birth causes bone deformations during the process is not an entirely well understood phenomenon. It is however clear that during the course of the disease, anatomical deformities can affect the entire pelvic limb leading to undesirable lameness may also be accompanied by further complications leading to poor quality of life including permanent pain and shorter life span. [3] The motion of the patella occurs in four different planes: flexion- extension, medial-lateral rotation, medial-lateral patellar tilt, and medial-lateral patellar shift. Its stability depends on trochlear groove depth and soft tissue stabilisers. Patellar dislocation is considered to result from disproportion between pelvic limb alignment, bony trochlear and patellar geometry, passive restraints of ligaments and retinaculum and the action of the quadriceps group of muscles (m.) namely m. rectus femoris, m. vastus intermedins, m. vastus lateralis and m. vastus medialis. [4] Clinical signs are variable and based on the severity of luxation. Animals of any age may be affected. In general terms, cats and small and miniature breeds of dogs display predominantly medial luxation, whereas large breed of dogs suffer largely from lateral luxation. Commonly, the affected animals are lame or ambulate with a skipping gait. Palpation of the stifle joint reveals displacement of the patella. [5] Patellar luxation can be classified according to the level of severity: [6] Grade 1 — Clinical signs can be very mild and the patella can be manually luxated to return to the trochlear groove. [7] Grade 2 — The patella luxates during flexion of the joint and is repositioned during extension. [8] Grade 3 — The dislocated patella is more frequently out of, rather than in, the trochlear groove - consistent lameness. [9] Grade 4 — Lameness and limb deformations are severe.

[10] Surgical correction is the usual treatment and is mainly based on the severity of the luxation and can include both orthopaedic and soft-tissue procedures. Some example procedures involve fascial releasing incisions (on the side of the treated luxation), joint capsule and retinaculum imbrications (on the side opposite the treated luxation), deepening of the trochlear groove, tibial crest transposition, and fabella to tibial tuberosity derotation sutures. Severe deformations may require femoral or tibial osteotomies, stifle joint arthrodesis, or limb amputation.

[11] The genetic basis of medial patellar luxation has long been known and supported by both the predisposition of certain breeds and the significant number of bilateral non-traumatic cases. Dogs with medial patellar luxation have abnormal development of the trochlear sulcus (trochlear dysplasia) and the degree of this abnormality varies from a nearly normal trochlea to an absent trochlear sulcus.

[12] The purpose of operative treatment m dogs with patellar luxation is to provide patellar stability and restore the normal mechanism of the quadriceps femoris muscle and its normal function. Surgery, upon detection at early stage of life, should not be delayed because of a tangible risk of worsening tissue damage and bone deformity. Operative methods in dogs with patellar luxation are mainly based on the specific anatomical deviations established after diagnosis. They can be classified into one of two main groups: soft tissue reconstructive methods and bone reconstructive methods, and often these groups of methods are combined.

[13] Soft tissue reconstructive techniques include desmotomy, soft tissue imbrication, tensor fasciae latae flap technique, and anti-rotational patellar suture. All of these methods could be considered to provide some level of assistance to the patient in that they lead to an improvement in the stability of the patella.

[14] However, each of these surgical methods requires for example laceration or removing a muscle or opening of the joint capsule which is complex, time consuming, traumatic to the patient, long time in surgery with prolonged recovery time and re-luxation.

[15] Therefore, there is a pressing need for a quick, minimally invasive and effective method for treating of patellar luxation which is characterised with rapid recovery and reduced re-luxation occurrence. SUMMARY OF THE INVENTION

[16] The inventors have developed a new method for treating patellar luxation. In particular, the inventors have developed a new method for treating low-grade patellar luxation. The inventors have developed a new and improved method for treating patellar luxation. The inventors have developed a new method for treating medial patellar luxation. The inventors have developed a new and improved method for treating medial patellar luxation. In particular, the inventors have developed a new, simple and effective method of treatment of patellar luxation in a patient. In particular, the inventors have developed a new, simple and effective method of treatment of medial patellar luxation in a patient. The inventors have developed a new, simple and effective method of treatment of patellar luxation in young patients. In particular, the inventors have developed a new, simple and effective method of treatment of medial patellar luxation in young patients.

[17] The inventors have developed a method for treating patellar luxation which is characterised with faster recovery rate. The inventors have developed a method for treating patellar luxation which is characterised with reduced re-luxation occurrence. The methods of the present invention are also directed to a reliable diagnosis of patellar luxation as well as more accurate determination of the likelihood of success of the treatment and concomitant reduction in re-luxation occurrence.

[18] In an aspect of the present invention, there is provided a method of treating patellar luxation in a patient, the method comprising the steps of: a. patient examination and imaging of the affected joint; b. comparing the image of the affected joint from step a. with the contralateral patient’s joint, prior to surgery; c. determining the course of action associated with the surgery on the affected joint.

[19] A particular advantage of the present method of treatment is that the knee joint is not incised. The lack of incision of the knee, makes the procedure particularly advantageous because it leads to a minimally invasive procedure with reduction in the duration of treatment such as surgery and anaesthesia period.

[20] In some embodiments of the present invention, the method comprises the step of examining the patient to determine patellar luxation and / or lameness grade.

[21] In some further embodiments, the patellar luxation and / or lameness grade in the patient is determined using patellar displacement test and / or imaging.

[22] According to some embodiments, the patient is a cat or a dog. In some further embodiments the patient is a young dog. In some further embodiments the patient is a young small breed dog.

[23] In some embodiments of the present invention, the image is generated using a scanning device. In some further embodiments, the scanning device is or comprises an ultrasound scanner, an x-ray device, radiological imaging, magnetic resonance imaging (MRI) and / or computed tomography (CT).

[24] In some embodiments of the present invention, the method comprises a step of diagnosing grade of luxation and / or type of trochlear dysplasia.

[25] In some embodiments of the present invention, the method comprises a step of establishing congenital and / or acquired anomalies associated with luxation of the patella.

[26] In some embodiments of the present invention, wherein the course of action of the present invention comprises a determination of the trochlear groove depth and / or trochlear dysplasia type of the patient’s joint, based at least partly, on the comparison in step b..

[27] In some embodiments of the present invention, the step of determining the trochlear groove depth and / or trochlear dysplasia type of the patient’s joint includes determining at least one of the parameters selected from the group comprising trochlear sulcus angle, trochlear sulcus depth, lateral trochlear inclination and medial trochlear inclination. 128] In some embodiments of the present invention, the method further comprises the step of incising subcutaneous tissue and / or the fascia latae and leaving the joint capsule intact. In some embodiments of the present invention, the method further comprises the step of adjusting the patella substantially centrally of the trochlear groove. According to some particular embodiments of the present invention, from the lateral side of the joint, soft tissue imbrication is performed in at least two points proximally and distally. According to some further particular embodiments of the present invention, from the medial side of the joint, soft tissue imbrication is performed in at least one point.

[29] In some embodiments of the present invention, the method further comprises the steps of providing means of enclosing the tendon of quadriceps femoris muscle proximally and distally to the patella from the lateral side and securing said means caudoproximally and caudodistally substantially close to the lateral fabella.

[30] In some embodiments of the present invention, the method comprises the step of providing means of enclosing the quadriceps muscle tendon on the medial side by the medial fabella. groove. According to some particular embodiments of the present invention, the said means retains the patellar substantially centrally within the determined dimensions of the trochlear groove or substantially in the trochlear groove.

[31] In some embodiments of the present invention, the method leads to a reduction in re-luxation recurrence. According to some particular embodiments of the present invention, the reduction in re-luxation recurrence is statistically significant compared to other treatment procedures.

[32] According to an aspect of the present invention, there is provided a system for determining or selecting a patient suffering with patellar luxation for treatment, the system comprising a processor configured for: i). comparing the image of the affected joint with the contralateral patient’s joint prior to surgery; and ii). optionally determining the trochlear groove depth and / or trochlear dysplasia type for the patient’s joint, based at least partly on the comparison in step i)..

[33] In some embodiments of the present invention, the system further comprises a scanning device for generating images before and after surgery, for determining at least one of the following parameters selected from the group consisting of trochlear sulcus angle, trochlear groove depth, lateral trochlear inclination and medial trochlear inclination from a joint.

[34] In some embodiments of the present invention, the system comprises determining or selecting a patient suffering with patellar luxation for treatment according to the methods of the present invention.

[35] According to an aspect of the present invention, there is provided a computer-readable medium having stored thereon, a computer program, which computer program, when executed by a computer, causes the computer to perform at least one of the steps m the method of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[36] FIGURE 1. Schematic representation of a joint affected by patella luxation depicted prior to and after treatment.

[37] FIGURE 2. Cartoon of a joint affected by patella luxation depicted after treatment.

[38] FIGURE 3A. X-ray image of lateral and medial trochlear inclination measurement.

[39] FIGURE 3B. X-ray image of sulcus angle measurement.

[40] FIGURE 3C. X-ray showing trochlear depth measurement

[41] FIGURE 4. Schematic representation of the patella luxation treatment methods

[42] FIGURE 5. Schematic representation of examination, imaging, processing, determination and generation of a database where the database can be used as a reference repository. DETAILED DESCRIPTION

[43] Throughout this disclosure, various scientific publications, patents and published patent specifications are referenced by an identifying citation. The disclosures of these publications, patents and published patent specifications are hereby incorporated by reference into the present disclosure to more fully describe the state of the art to which this disclosure pertains.

[44] As used herein, certain terms may have the following defined meanings.

[45] As used herein the term “subject” or “patient” are used interchangeably and mean a vertebrate, such as a four-legged animal. Preferably the subject is a canine or a feline. Preferably the subject is a cat or a dog. Preferably the patient is a young dog or a young cat. Preferably the patient is a young small breed dog. In some embodiments of the present invention, the patient is a young dog or a young cat.

[46] As used in the specification and the claims, the singular form “a,” “an” and “the” include singular and plural references unless the context clearly dictates otherwise. For example, the term “patellar luxation” refers to a displacement of a patella such as medial and / or lateral relative to the joint of the patient. In the context of the present invention, the patellar luxation can be graded such as grades 1 to 4. In the context of the present invention, the sutures maintain the correct position of the quadriceps mechanism, and the patella exerts mechanical pressure on the femoral trochlea, which reaches the appropriate depth.

[47] As used herein, the term "comprising" means including, made up of, composed of encompass, consist of, constitute and incorporate.

[48] All numbers or numerals as used herein that indicate amounts, ratios of materials, physical properties of materials, and / or use are to be understood as modified or qualified by the term "about," except as otherwise explicitly indicated.

[49] As used herein, the term "about" includes the recited number or number and + / - 10% from the recited numeral or number. By way of non-limiting example, the term "about ten (10)" would encompass nine (9) to eleven (11) or 9-11.

[50] The term “substantially” refers to up to 80% or more of an entirety. Recitation of ranges of values herein are not intended to be limiting, referring instead individually to any and all values falling within the range, unless otherwise indicated, and each separate value within such a range is incorporated into the specification as if it were individually recited herein. By way of example, according to the present invention, the patellar is positioned substantially centrally in the trochlear groove of the affected joint.

[51] As used herein, the term "substantially free" means that the content is sufficiently low or negligent that no appreciable danger to the patient will result from exposure during any of the methods of the present invention.

[52] For purposes of this disclosure, the term “aligned” means parallel or substantially parallel. Also, for purposes of this disclosure, the term “length” means the longest dimension of an object such as trochlear. Also, for purposes of this disclosure, the term “width” means the dimension of an object from side to side. For the purposes of this disclosure, the term “above” generally means superjacent, substantially supeijacent, or higher than another object although not directly overlying the object. Further, for purposes of this disclosure, the term “mechanical communication” generally refers to components being in direct physical contact with each other or being in indirect physical contact with each other where movement of one component affect the position of the other.

[53] As used herein, the term “at least one”, unless otherwise indicated, refers to one or more steps, images, examinations, sutures, imbrication, means of enclosing a tendon, biomarker which can be used in the methods of the present invention. By way of example, at least one examination means one examination or type of examination, it also refers to 2 examinations or types of examination, it also refers to 3 examinations or types of examination, it also refers to 4 examinations or types of examination or more; at least one image means one image derived from any scanning device, it also refers to 2 images derived from any scanning device or more, it also refers to 3 images derived from any scanning device or more, it also refers to 4 images derived from any scanning device or more; at least one suture means one suture, it also refers to 2 sutures, it also refers to 3 sutures, it also refers to 4 sutures or more; at least one imbrication means one imbrication, it also refers to 2 imbrications, it also refers to 3 imbrications, it also refers to 4 imbrications or more. The term “biomarker” as used herein, refers to a characteristic that can be objectively measured and evaluated as an indicator of normal and disease processes or physiological response. A “biomarker” is a parameter that can be used to measure the onset or progress of disease or condition or the effect of treatment. The parameter can be chemical, physical, biological or behavioural. Preferably, the disease is patellar luxation. Preferably tire disease is congenital, developmental, or traumatic patellar luxation. By way of example, biomarker can be, grade of luxation, trochlear angle and others.

[54] As used herein, the term “treatment” or “treating” refers to an amelioration, prophylaxis, or reversal of a disease or disorder, or of at least one discernible symptom or condition thereof in a patient such as an animal. It is also contemplated that the treatment, as described herein throughout and based on data, leads to one or more of clinical improvement, reduction in the severity of a symptom or disease and reduction in re-luxation recurrence or lameness. It is also contemplated that the treatment, as described herein throughout and based on data, leads to clinical improvement and enhancement of rate of recovery. In some embodiments, “treatment” or “treating” refers to an amelioration, prophylaxis, or reversal of at least one measurable physical parameter related to the disease or disorder being treated, not necessarily discernible in or by the patient such as the animal. In some embodiments, “treatment” or “treating” refers to inhibiting or slowing the progression of a disease, disorder or condition, either physically, e.g., stabilisation of a discernible symptom, physiologically, e.g., stabilisation of a physical parameter, or both. In some embodiments, “treatment” leads to partial or complete remission of the disease or disorder. In some embodiments, “treatment” leads to clinical improvement in an animal affected by patellar luxation such as medial patellar luxation. In some embodiments, “treatment” leads to reduction in the severity of disease in an animal affected by patellar luxation such as medial patellar luxation. In some embodiments, “treatment” leads to reduction in the recurrence of disease in an animal affected by patellar luxation such as medial patellar luxation. In some embodiments, “treatment” leads to clinical improvement and enhancement of the rate of recovery of an animal affected by patellar luxation such as medial patellar luxation. In some embodiments, “treatment” leads to clinical improvement or substantial reversal of lameness in an animal affected by patellar luxation such as medial patellar luxation.

[55] Patella luxation typically occurs as a congenital defect in animals, although it can sometimes also occur as the result of trauma. Medial luxation is more common in smaller breeds, whereas lateral luxation is more common in larger breeds. Luxation itself can cause significant pain and discomfort due to an abnormal gait. However, where it results from a congenital defect or trauma in a young animal, the forces that are abnormally directed due the luxation can result in further and even worse deformations of the femur and tibia during further growth and maturation. Moreover, failure of the patella and ligament to track in the groove, or riding on a trochlear ridge, can cause a ridge to become worn down or flattened and failure of the groove to form to a normal depth. This can result in exposure of sub-chondral bone on the ridge, which can cause significant pain and suffering to the patient.

[56] Difficulties can also occur where the patella lies proximal to the trochlea groove when the leg is extended, for example due to a long patellar ligament so the trochlear ridges fail to provide an effective medial or lateral barrier, enabling easy patella dislocation in an animal due to conformational abnormality.

[57] The present inventors have conducted their assessments with the understanding that it is strongly preferable to correct patellar luxation at an early stage as possible, to avoid bone deformation as the animal grows, to promote correct formation of the trochlear groove and to prevent deterioration as a result of the abnormal direction of forces exerted by the misaligned quadriceps mechanism. Untreated, patellar luxation may lead to osteoarthritis and progressive degenerative joint disease.

[58] Without wishing to be bound by theory, patellar luxation is a significant problem for dogs and cats as described herein. In approximately 85% of patients, patellar luxation is medial, and in some patients, it is often bilateral. Small and tiny dog breeds are predominantly affected such as Pinscher, Pomeranian, Yorkshire Terrier, Chihuahua and others and these can suffer unquantifiable discomfort and pain. The terms "dog" and "cat" encompass all canines and all felines respectively and is not limited to domesticated animals. By way of example, the dog lifespan encompasses a number of dog life stages: For the first six to eight months of life, they are puppies. Then from six to eight months until about die age of 18 months to two years, they are adolescents. From that point until they are 75 percent into their expected life span (which varies by size and breed of dog), they are adult dogs. For the last 25 percent of their expected lifespan, they are considered senior dogs, when they are also said to be in their golden years, or referred to as “gray hairs’’. By way of example, as used here, the term dog encompasses any size or age of dog. In some embodiments, the term “dog” encompasses small and tiny dog breeds. In some embodiments, the term “dog” encompasses dog breeds selected from the group comprising Pinscher, Pomeranian, Yorkshire Terrier, Chihuahua and others.

[59] The present invention is predicated, in part, on the observation by the inventor that the geometry of the trochlea is substantially constant irrespective of the breed and size of dog. It is expected that this will be the case across all canines. It is further expected that felines and other four-legged animals will have a substantially constant trochlea geometry. Figures 3A. 3B and 3C show how the span of a trochlea ridge can be determined by measuring in a straight line from opposite end points of the trochlear ridge, specifically from the proximal point of the cartilage on the trochlear ridge to the level of the condylar notch. Similarly, the ridge height can be determined by measuring the distance from the middle of the ridge span to the top of the troch ridge, with the ridge hight being perpendicular to the ridge span. The ridge span measurement is relatively easy to determine from a single x ray of the knee (stifle) joint. In particular, Figure 3C shows a line extending across the condyle at the distal end, which represents the intercondylar depth (TD). This line can also be seen on the mediolateral radiograph shown in Figure 3A. The condylar notch is in the middle of the distal femur and the location of the condylar notch corresponds to where this line begins. Thus, the ridge span can be measured in a mediolateral radiograph of the stifle joint from where this line originates to the proximal extent of the trochlear cartilage, where the curvature of the trochlea ends. The sulcus angle is determined as shown in the X ray image in Figure 3B.

[60] The inventors have developed a simple, effective and quick method for treating patellar luxation where the method is characterised with faster recovery rate and reduction in re-luxation occurrence.

[61] In an aspect of the present invention, there is provided a method of treating patellar luxation in a patient, the method comprising the steps of: a. patient examination and imaging of the affected joint; b. comparing the image of the affected joint from step a. with the contralateral patient’s joint, prior to surgery'; c. determining the course of action associated with the surgery on the affected joint.

[62] A particular advantage of the present method of treatment is that the knee joint is not incised. The lack of incision of the knee, makes the procedure particularly advantageous because it leads to a minimally invasive procedure with reduction in the duration of treatment such as surgery theatre time and anaesthesia period. In some embodiments of the present invention, the patient examination is physical examination tests. In some embodiments of the present invention, the patient examination is a bilateral physical examination test.

[63] Those of skill in the art would be familiar with different physical examination tests, clinical examination tests such as orthopaedic examination tests, and imaging. Those of skill in the art would also know that there is frequently inconsistency or even discrepancies between different physical and clinical tests such as patellar displacement tests, relative to imaging. It is therefore preferred that a combination of tests and imaging is used in the methods of the present invention. In some preferred embodiments of the present invention, a combination of tests and imaging is used in patellar luxation classification according to the level of severity' such as Grade, 1, Grade 2, Grade 3 and Grade 4. In some preferred embodiments of the present invention, a combination of tests and imaging is used in determining lameness. In some preferred embodiments of the present invention, a combination of tests and imaging is used in grading lameness. In some embodiments of the present invention, the method comprises a step of diagnosing the grade of luxation and / or type of trochlear dysplasia.

[64] In some embodiments of the present invention, the method comprises a step of establishing congenital and / or acquired anomalies associated with luxation of the patella.

[65] In some embodiments of the present invention, wherein the course of action of the present invention comprises a determination of the trochlear groove depth and / or trochlear dysplasia type of the patient’s joint, based at least partly, on the comparison in step b..

[66] In some embodiments of the present invention, the method comprises the step of examining the patient to determine patellar luxation and / or lameness grade.

[67] In some further embodiments of the present invention, the patellar luxation and / or lameness grade in the patient is determined using patellar displacement test and / or imaging.

[68] According to some embodiments of the present invention, the patient is a cat or a dog. In some further embodiments the patient is a young dog. In some further embodiments of the present invention, the patient is a young small breed dog. In some further embodiments of the present invention the young small dog breed is selected from the group comprising Pinscher, Pomeranian, Yorkshire Terrier, Chihuahua and others.

[69] In some embodiments of the present invention, the image is generated using a scanning device. In some further embodiments, the scanning device is or comprises an ultrasound scanner, an x-ray device, radiological imaging, magnetic resonance imaging (MRI) and / or computed tomography (CT). In some embodiments of the present invention, the scanning device is an x-ray device. In some embodiments of the present invention the image is that of an x ray. Referring here to Figures 3A, 3B and 3C. Figure 3C shows a line extending across the condyle at the distal end, which represents the intercondylar depth (TD). This line can also be discerned from the mediolateral radiograph of Figure 3A. The sulcus angle is shown in the x ray image in Figure 3B.

[70] In some embodiments of the present invention, the step of determining the trochlear groove depth and / or trochlear dysplasia type of the patient’s joint includes determining at least one of the parameters selected from the group comprising trochlear sulcus angle, trochlear sulcus depth, lateral trochlear inclination and medial trochlear inclination. In some embodiments of the present invention the trochlear sulcus angle, trochlear sulcus depth, lateral trochlear inclination and medial trochlear inclination are determined using on x ray images. In some embodiments of the present invention at least one in the group of consisting of trochlear sulcus angle, trochlear sulcus depth, lateral trochlear inclination and medial trochlear inclination, are determined using images such as x ray images.

[71] In some embodiments of the present invention, the method further comprises the step of incising subcutaneous tissue and / or the fascia latae and leaving the joint capsule intact. In some embodiments of the present invention, the method further comprises the step of adjusting the patella substantially centrally of the trochlear groove. According to some particular embodiments of the present invention, from the lateral side of the joint, soft tissue imbrication is performed in at least two points proximally and distally. According to some further particular embodiments of the present invention, from the medial side of the joint, soft tissue imbrication is performed in at least one point.

[72] In some embodiments of the present invention, the method further comprises the steps of providing means of enclosing the tendon of quadriceps femoris muscle proximally and distally to the patella from the lateral side and securing said means caudoproximally and caudodistally substantially close to the lateral fabella.

[73] In some embodiments of the present invention, the method comprises the step of providing means of enclosing the quadriceps muscle tendon on the medial side by the medial fabella groove. According to some particular embodiments of the present invention, the said means retains the patellar substantially centrally within the determined dimensions of the trochlear groove or substantially in the trochlear groove. In some embodiments of the present invention, the medial suture restricts movement and retains the patella in the trochlear groove centre.

[74] In some embodiments of the present invention, the method leads to a reduction in re-luxation recurrence. According to some particular embodiments of the present invention, the reduction in re-luxation recurrence is statistically significant compared to other treatment procedures or relative to placebo.

[75] In some embodiments of the present invention, the method leads to a reduction in lameness. According to some particular embodiments of the present invention, the reduction in lameness is statistically significant compared to other treatment procedures or relative to placebo.

[76] It is further contemplated that the methods of the present invention can advantageously be adapted to effectively treat patients with congenital, developmental, or traumatic patellar luxation. In some embodiments, the methods of the present invention are used for the treatment of congenital, developmental, or traumatic patellar luxation.

[77] As used herein, the term “alteration” may be used interchangeably with the terms, “alter” or “modify” such as increase or decrease in the level of a metabolite such as a chemical or a biomarker detected and / or analysed and / or monitored, by the device of the present invention. The terms “decrease” and “reduce” can be used here interchangeably.

[78] In some embodiments, the alteration is at least 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95% or 100% or greater compared to control or base level.

[79] According to an aspect of the present invention, there is provided a system for determining or selecting a patient suffering with patellar luxation for treatment, the system comprising a processor configured for: i). comparing the image of the affected joint with the contralateral patient’s joint prior to surgery; and ii). optionally determining the trochlear groove depth and / or trochlear dysplasia type for the patient’s joint, based at least partly on the comparison in step i)..

[80] With reference here to figures 3A, 3B, 3C which show x ray images and Figure 4 which shows a schematic of a system for comparing images such as x ray images and optionally determining the trochlear groove depth and / or trochlear dysplasia type for the patient’s joint. In some embodiments of the present invention, the system for determining or selecting a patient suffering with patellar luxation for treatment comprises a processor. In some embodiments of the present invention, the system for determining or selecting a patient suffering with patellar luxation for treatment comprises a processor such as a computer configured to measure at least one of the sulcus angle, trochlear depth, lateral inclination and the medial inclination.

[81] In some embodiments of the present invention, the system further comprises a scanning device for generating images before and after surgery, for determining at least one of the following parameters selected from the group consisting of trochlear sulcus angle, trochlear groove depth, lateral trochlear inclination and medial trochlear inclination from a joint.

[82] In some embodiments of the present invention, the system comprises determining or selecting a patient suffering with patellar luxation for treatment according to the methods of the present invention.

[83] According to an aspect of the present invention, there is provided a computer-readable medium having stored thereon, a computer program, which computer program, when executed by a computer, causes the computer to perform at least one of the steps in the method of the present invention. Data Processing

[84] In some embodiments, the data, such as reports of examinations, readings, determinations and images collected during the methods of the present invention, can be processed on a processor such as a computer in situ or remotely. Reference here is made to Figure 5, providing a schematic representation of a diagram: data collection, correlation using mathematical manipulation and software analysis of the data e.g. by in situ computer system, transmittal and storage of the data on a Server / iCloud; and generating reference database for downstream uses.

[85] After normalisation and pre-processing of the data, MetIDQ™ software (Biocrates) can be used for peak integration and calculation. In some further embodiments, the data collected from the device has to be processed using machine learning and simulated training data.

[86] The present disclosure further contemplates that the entities that may be responsible for the collection, analysis, disclosure, transfer, storage, or other use of any personal information data will comply with well-established privacy policies and / or privacy practices. In particular, such entities should implement and consistently use privacy policies and practices that are generally recognised as meeting or exceeding industry or governmental requirements for maintaining personal information data private and secure, including the use of data encryption and security methods that at least meets or may even exceed industry or government standards.

[87] An embodiment of the present disclosure may also be implemented in the form of a recording medium including instructions executable by a computer, such as a program module executed by the computer. Computer-readable media may be any available media that may be accessed by a computer and include both volatile and nonvolatile media and removable and non-removable media. In addition, the computer-readable media may include all computer storage media. The computer storage media includes both volatile and nonvolatile media and removable and non-removable media implemented by any method or technology of storing information, such as a computer readable instruction, a data structure, a program module, and other data. Statistical Analysis

[88] Analysis can be carried out on the device itself or remotely using systems and software programs known in the art such as for example IBM SPSS version 25. Variables in measurement and data with skewed distributions can be log-transformed to ensure normality. Comparisons can be performed with t-test, Wilcoxon-Mann-Whitney, and one-way ANOVA as appropriate. Significance was defined as p<0.05. Non-parametric tests were used for comparing ordinal or non-nonnal variables. Data can be presented as mean standard deviation (mSD).

[89] In further embodiments, the present disclosure may also be implemented in the form of a recording medium including instructions executable by a computer, such as a program module executed by the computer. Computer-readable media may be any available media that may be accessed by a computer and include both volatile and nonvolatile media and removable and non-removable media. In addition, the computer-readable media may include all computer storage media. The computer storage media includes both volatile and nonvolatile media and removable and non-removable media implemented by any method or technology of storing information, such as a computer readable instruction, a data structure, a program module, and other data. Tire storage may be in the iCloud.

[90] In some embodiments, the computer-readable medium having stored thereon, a computer program, which computer program, when executed by a computer, causes the computer to perform at least one of the steps in the method of the present invention. In some embodiments, the computer-readable medium having stored thereon, a computer program, which computer program, when executed by a computer, causes the computer to perform at least one diagnostic determination characterised with or associated with patellar luxation. In some embodiments, the computer-readable medium having stored thereon, a computer program, which computer program, when executed by a computer, causes the computer to perform at least one step of diagnosing grade of luxation and / or type of trochlear dysplasia.

[91] The use of any and all examples, or exemplary language (“e.g.,” “such as,” or the like) provided herein, is intended merely to better illuminate the embodiments and does not pose a limitation on the scope of the embodiments or the claims. No language in the specification should be construed as indicating any unclaimed element as essential to the practice of the disclosed embodiments.

[92] In the following description, it is understood that terms such as “first,” “second,” “top,” “bottom,” “up,” “down”, "upper", "lower", "above", "below", "beneath", "front", "back", "over", "under", "left", "right", “dorsal”, “volar”, “palm side”, “back side” etc. are used with reference to the orientation of some of the components of the medical device of the present invention. Since constituents or components in various embodiments described here can be positioned in a number of different orientations, locations of the body, directional terminology is used for purposes of illustration only and is in no way limiting. The directional terminology is intended to be construed broadly, and therefore should not be interpreted to preclude components being oriented in different ways.

[93] Additionally, the terms and expressions employed herein have been used as terms of description and not of limitation, and there is no intention in the use of such terms and expressions of excluding any equivalents of the features shown and described or portions thereof, but it is recognized that various modifications are possible within the scope of the disclosure claimed. It will also be appreciated that the device(s), method(s), use(s), detector(s), sensor(s), physiological biomarker(s) may be subject to numerous rearrangements, modifications and substitutions without departing from the scope of the present disclosure as set forth and defined by the following claims.

[94] In order that the invention may be readily understood and put into practical effect, particular embodiments will now be described by way of the following non-limiting examples. MATERIAL, METHODS AND EXAMPLES

[95] General methods for surgical status evaluation; examination of flexion, extension of the respective joints; specific tests to distinguish congenital from traumatic luxation; metric measurements of the trochlear groove of the femur; goniometric measurements.

[96] Imaging methods: Computed tomography and / or X-ray for diagnosis of the grade of luxation and trochlear dysplasia and establishment of congenital and acquired anomalies associated with luxation of the patella.

[97] Surgical methods: Extracapsular technique for treatment of patellar luxation and prevention of bone deformities in the growth period and control of postoperative pain.

[98] Statistical methods: Through routine statistical tests, the obtained data will be processed and compared with other operational techniques.

[99] Introduction of new methods: Introduction and validation of the triple anti-luxation patellar suture (TAPS) as an operative method for the treatment of low-grade medial patellar luxation in young small breed dogs.

[100] Application of a novel minimally invasive method of treatment of low-grade medial patellar luxation in dogs from small breeds at an early age without exposure of the stifle joint. The technique is tentatively termed “triple antiluxation patellar suture'’ (TAPS). Its main goal is to retain (fix) the patella in the centre of the trochlear groove during the growth period. Thus, the patella will exert a mechanical pressure on the trochlear articular cartilage until the depth of the trochlea becomes sufficient. Through the TAPS, the contact areas between the convex patellar articular surface and the trochlear groove surface will become larger and thus, the function of the femoropatellar joints will be improved. The TAPS method is minimally invasive because it does not include opening of the joint capsule; the operation time is also reduced. Unlike other operative techniques, TAPS is intended to be applied at 4-6 months of age without risk from affection of growth plates. After craniolateral approach, only the skin, subcutaneous tissue and the fascia latae are incised; the joint capsule remains intact. After visualisation of the patella, it is positioned in the trochlear groove centre. At a distance of 1-2 mm from its lateral side, soft tissue imbrication is performed in two points: proximally and distally, whereas from the medial side, it is done in a single point (the centre). Thus, the suture pattern resembles that of a checkerboard. A Mayo mattress suture is used, enclosing the tendon of m. quadriceps femoris proximally and distally to the patella from the lateral side, and in the final stage, the knot is tied caudoproximally and caudodistally close to the lateral labella A single Mayo mattress suture is placed on the medial side, which also encloses the quadriceps muscle tendon with knot tied close to the medial fabella. The medial suture is a kind of a “stop” retaining the patella in the trochlear groove centre.

[101] The triple antiluxation patellar suture is not expensive, easily applicable, minimally invasive (because the joint capsule is not incised). The operation duration is minimal, and the recovery - shorter compared to other surgical techniques.

[102] 1) The method of our invention can result in deepening of the trochlear groove, proper functioning of the quadriceps mechanism and prevention of clinical medial patellar luxation?

[103] 2) The method can prevent pelvic limbs malalignment during the growth period in small dog breeds, which are genetically predisposed to medial patellar luxation.

[104] Our methods show that a retention of the patella within the trochlear groove by the suture influenced the trochlear articular cartilage, which is soft and elastic during the growth period and thus, susceptible to mechanical impact. The contact areas between the convex patellar articular surface and the trochlear groove surface became larger, the trochlea reached the necessary depth and ultimately, the quadriceps mechanism functioned properly i.e. as intended.

[105] The proposed novel method which in this present example is represented by a triple antiluxation patellar suture i.e. TAPS, maintained the correct position of the patella in the centre of the trochlear groove, guaranteeing constant mechanical pressure on the trochlear articular cartilage. At the same time, TAPS can keep the quadriceps mechanism aligned relative to the trochlear groove, the patella and tuberositas tibiae, thereby preventing bone deformities.

[106] The presently described minimally invasive method is accompanied by faster recovery, a lower percentage of postoperative complications and recurrence rates. This will be entirely for the benefit of patient health, to which we are committed.

[107] We surprisingly and unexpectedly observed that our method was able to deepen the trochlear groove without exposure of the knee joint and result in proper functioning of the quadriceps mechanism of the leg thus solving a cardinal problem in this genetic disease.

[108] Our results also provided a much, needed clarification of some of the causal relationships of patellar luxation in small breed dogs, changes in the knee joint and surrounding topographical areas.

[109] In addition, our methods were able to deliver a patellar suture stabilisation of the knee cap and improve the biomechanics of the knee joint as a whole without need for knee joint incision. EXPERIMENTAL EXAMPLE [HO] The included dogs will be selected among the animals which satisfy specific inclusion criteria (young dogs from small breeds from 4-6 months to 2 years of age; radiological evidence for a shallow trochlear groove) and after consent from their owners. They will be duly registered in specially designed questionnaires. [Hl] Examination methods

[112] The patellar luxation and lameness grades were determined using the patellar displacement test and diagnostic imaging approaches (radiolog}--, computed tomography). The trochlear groove depth and trochlear dysplasia type were determined on three dimensional reconstruction images as shown in Figures 2. Post operatively, the same examinations and assessments were repeated. The Cook’s criteria for reporting time frame, outcome, and complications for clinical orthopaedic studies in veterinary medicine were used (https: / / experts.umn.edu / en / publications / proposed-defmitions-and-criteria-for-reporting-time-frame-outcom). Treatment

[113] We used a novel minimally invasive method of treatment of medial patellar luxation in dogs from small breeds at an early age without exposure of the stifle joint.

[114] The exemplar}' technique is termed “triple anti-luxation patellar suture” (TAPS) as shown in Figure 1 and Figure 2.

[115] However, modifications of the TAPS technique may also be used on different patients such as for instance greater number of sutures. The number of sutures may vary depending on for instance the size and weight of the patient.

[116] The intention is to retain (fix) the patella in the centre of the trochlear groove during the growth period. The patella can then exert a mechanical pressure on the trochlear articular cartilage until the depth of the trochlea becomes sufficient.

[117] Through TAPS, the contact areas between the convex patellar articular surface and the trochlear groove surface become larger and thus, the function of the femoropatellar joints is improved.

[118] The TAPS method we developed is minimally invasive because it does not include opening of the joint capsule. Moreover, there is no laceration or removal of a muscle tissue or tendons. The operation time is reduced which is an additional advantage because it not only reduces the period of time the patient in the theatre and associated complications but also offers real cost saving.

[119] Unlike other operative techniques, the present methods such as the exemplary TAPS technique, is advantageously applied at less than 10 months of age of the patient, preferably less than 9 months of age of the patient, preferably less than 8 months of age of the patient, preferably less than 6 months of age of the patient, preferably between 4 to 6 months of die age of the patient, without risk from affection of growth plates.

[120] After craniolateral approach, only the skin and the subcutaneous tissue are incised but importantly, the joint capsule remains intact.

[121] After visualisation of the patella, the patella is positioned in the trochlear groove centre.

[122] At a distance of 1 -2 mm from its lateral side, soft tissue imbrication is performed in two points: proximally and distally, whereas from the medial side, it is done in a single, preferably the central point. Thus, the suture pattern resembles that of a checkerboard.

[123] A Mayo mattress suture is used, enclosing the tendon of m. quadriceps femoris proximally and distally to the patella from the lateral side, and in the final stage, the knot is tied caudoproximally and caudodistally close to the lateral fabella. A single Mayo mattress suture is placed on the medial side, which also encloses the quadriceps muscle tendon with a knot tied close to the medial fabella. The medial suture restricts movement and retains the patella in the trochlear groove centre. CONCLUSION

[124] The triple antiluxation patellar suture is not expensive, easily applicable, minimally invasive (because the joint capsule is not incised and no muscle tissue or tendons are lacerated). The operation duration is minimal, and the recovery - shorter compared to other surgical techniques.

[125] The triple antiluxation patellar suture has the advantage that it is not expensive, easily applicable, minimally invasive (because the joint capsule is not incised), the operation duration is minimal, shorter and better recovery of patients is anticipated compared to other more invasive surgical techniques. Secondary osteoarthritis complications are also significantly reduced. * * *

[126] The disclosure illustratively described herein can suitably be practiced in the absence of any element or elements, limitation or limitations, not specifically disclosed herein. Thus, for example, the terms “comprising’', “including, ’’containing”, etc. shall be read expansively and without limitation. Additionally, the terms and expressions employed herein have been used as terms of description and not of limitation, and there is no intention in the use of such terms and expressions of excluding any equivalents of the features shown and described or portions thereof, but it is recognized that various modifications are possible within the scope of the disclosure claimed.

Claims

1. A method of treating patellar luxation in a patient, the method comprising the steps of:a. patient examination and imaging of the affected joint;b. comparing the image of the affected joint from step a. with the contralateral patient’s joint, prior to surgery;c. determining the course of action associated with the surgery on the affected joint.

2. A method according to claim 1. further comprising the step of examining the patient to determine patellar luxation and / or lameness grade.

3. A method according to claim 2, wherein the patellar luxation and / or lameness grade is determined using patellar displacement test and / or imaging.

4. A method of treating patellar luxation according to claim 1, wherein the patient is a cat or a dog.

5. A method of treating patellar luxation according to claim 4, wherein the patient is a young dog or a young small breed dog.

6. A method of treating patellar luxation according to claim 5, wherein the young dog or a young small breed dog is less than 10.5 months old, preferably the young dog or a young small breed dog is less than 9.5 months old, preferably the young dog or a young small breed dog is less than 8.5 months old, preferably the young dog or a young small breed dog is less than 7.5 months old, preferably the young dog or a young small breed dog is less than 6.6 months old, preferably the young dog or a young small breed dog is less than 5.5 months old, preferably the young dog or a young small breed dog is less than 4.5 months old, preferably the young dog or a young small breed dog is less than 4 months old, or younger.

7. A method of treating patellar luxation according to anyone of claims 1 to 3, wherein die image is generated using a scanning device.

8. A method of treating patellar luxation according to claim 7, wherein the scanning device is or comprises an ultrasound scanner, an x-ray device, radiological imaging, magnetic resonance imaging (MR1) and / or computed tomography (CT).

9. A method of treating patellar luxation according to claim 1, wherein the comparison of step b. further comprises the step of diagnosing grade of luxation and / or type of trochlear dysplasia.

10. A method of treating patellar luxation according to claim 1, wherein the comparison of step b. further comprises establishing congenital and / or acquired anomalies associated with luxation of the patella.

11. A method of treating patellar luxation according to anyone of the preceding claims, wherein the course of action comprises a determination of the trochlear groove depth and / or trochlear dysplasia type of the patient's joint, based at least partly, on the comparison in step b..

12. A method of treating patellar luxation according to claim 11, wherein the step of determining the trochlear groove depth and / or trochlear dysplasia type of the patient’s joint includes determining at least one of the parameters selected from the group comprising trochlear sulcus angle, trochlear sulcus depth, lateral trochlear inclination and medial trochlear inclination.

13. A method of treating patellar luxation according to anyone of the preceding claims, the method further including incising subcutaneous tissue and / or the fascia latae and leaving the joint capsule intact.

14. A method of treating patellar luxation according to claim 13, the method further comprises the step of adjusting the patella substantially centrally of the trochlear groove.

15. A method of treating patellar luxation according to anyone of claims 13 or 14, where from the lateral side of the joint, soft tissue imbrication is performed in at least two points proximally and distally.

16. A method of treating patellar luxation according to claim 15, where from the medial side of the joint, soft tissue imbrication is performed in at least one point.

17. A method of treating patellar luxation according to anyone of the preceding claims, further comprising the steps of providing means of enclosing the tendon of median quadriceps femoris proximally and distally to the patella from the lateral side and securing said means caudoproximally and caudodistally substantially close to the lateral fabella.

18. A method of treating patellar luxation according to anyone of claims 13 to 17, further comprising the step of providing means of enclosing the quadriceps muscle tendon on the medial side by the medial fabella.

19. A method of treating patellar luxation according to claim 18, wherein the said means retains the patellar substantially centrally in the trochlear groove.

20. A method of treating patellar luxation according to anyone of claims 1 to 19, where the method leads to a reduction in re-luxation recurrence.

21. A method according to claim 20, wherein the reduction in re-luxation recurrence is statistically significant compared to other treatment procedures.

22. A system for determining or selecting a patient suffering with patellar luxation for treatment, the system comprising a processor configured for:i). comparing the image of the affected joint with the contralateral patient’s joint prior to surgery; andii). optionally determining the trochlear groove depth and / or trochlear dysplasia type for the patient’s joint, based at least partly on the comparison in step i)..

23. A system for determining or selecting a patient suffering with patellar luxation for treatment according to anyone of claims 21 or 22, further comprising a scanning device for generating images before and after surgery, for determining at least one of the fol lowing parameters selected from the group consisting of trochlear sulcus angle, trochlear groove depth, lateral trochlear inclination and medial trochlear inclination from a joint.

24. A system for determining or selecting a patient suffering with patellar luxation for treatment according to anyone of claims 22 or 23, for use in the method of any one of claims 1 to 21.

25. A computer-readable medium having stored thereon, a computer program, which computer program, when executed by a computer, causes the computer to perform at least one of the steps in the method as claimed in any one of claims 1 to 21.

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