About this trial
Young patients who require total knee arthroplasty with metallic and plastic implants will undergo femoral condyle cartilage and top of the tibia with meniscus replacement. With the proposed surgery patients will have increased range of movements so that they can sit on the ground to fulfill their social was of life, which is not possible with the standard of care total knee replacement.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Being between 45 and 70 years of age of either gender. (OAK is common in this Age group)
Diagnosed with OAK with Kellgren and Lawrence Grading III and IV.
No ligamentous laxity and varus or valgus deformity. (In standard TKR patients with ligamentous laxity Constrained Condylar Knee (CCK) with intramedullary stem is used).
Patients who wish to have an active lifestyle.
Disqualifiers
Previous knee surgery within six months.
Uncontrolled Diabetes Mellitus
Chronic Kidney Disease. (Patients on hemodialysis)
Metabolic bone disease. (Severe osteoporosis with T Score of -<3.5)
Trial design
Single group
Treatments tested in this trial
Total osteo-cartilage replacement of the distal femur and proximal tibia, including medial and lateral meniscus.
Biological/VaccineIN total knee replacement metallic and plastic implant is used but in this procedure allograft with bone, cartilage and meniscus will be used.
allogenic bone and cartilage graft
DeviceIn this study allograft will be used instead of metallic and plastic implants.
Treatment groups
Trial outcomes
Primary outcomes
Assessment of Allograft in osteoarthritis of knee
The outcome of the allograft will be assessed by union of the allograft with the native bone.
assessment range of movements using WOMAC (Western Ontario University McMaster Osteoarthritis Index) .
pain=0-20, stiffness=0-8, physical function=0-68. a total WOMAC score is created by summing the items for all three subscales (max score 96).
Sponsors and contacts
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