Chondrofix Osteochondral Allograft Prospective Study

This is an interventional treatment trial for Articular Cartilage Disorder focused on measuring Knee, Femur, Articular cartilage, Lesions, Defects, Osteochondral graft, Cartilage treatments, Osteochondritis Dissecans, OCD Read More

Inclusion Criteria:

Generally, the following inclusion criteria must be met, however, this is not a complete list.

• Male and non-pregnant female subjects between 18 and 70 years; subject must be skeletally mature
• If female, subjects are not pregnant at time of surgery and do not plan on becoming pregnant during the first 24 months of the study
• Up to two (2) cartilage lesion(s), each measuring less than 8 cm2, of the femoral condyle or trochlear groove of the knee
• Localized knee pain unresponsive to conservative treatment (e.g., medication, bracing, physical therapy) and/or previous surgical intervention

Exclusion Criteria:

Generally, if a potential participant meets any of the following criteria, they will not be eligible for this study. Additionally, more criteria will be evaluated to confirm eligibility as this list is not a complete list of criteria.

• Concurrent participation in another clinical trial
• Cartilage lesion location is such that the implanted graft(s) will not be adequately shouldered
• Bipolar articular cartilage involvement (or kissing lesions) of the ipsilateral compartment (i.e., > than ICRS Grade 2 on the opposing articular surface)
• Is receiving pain medication other than NSAIDs or acetaminophen for conditions unrelated to the index knee condition
• Subject had any other cartilage repair procedure other than debridement performed in conjunction with or 6 months prior to implantation of a Chondrofix Osteochondral Allograft
• Prior or concurrent total meniscectomy of the index knee
• Uncorrected mal-alignment of the index knee
• Have smoked or used nicotine products within the past 6 months
• Body Mass Index > 35 (BMI=kg/m2)
• Has any contraindications for MRI
• Requires any of the following concomitant procedures performed in conjunction with or has had performed within 6 months prior to implantation of a Chondrofix Allograft: distal realignment, high tibial osteotomy, ligament reconstruction, and/or patellar realignment procedure
• Septic or reactive arthritis or systemic disease (e.g., rheumatoid arthritis, gout or prior history of gout or pseudo gout)
• Sickle cell disease, hemochromatosis, or autoimmune disease
• Unstable cardiovascular, renal, hepatic, endocrine and/or pulmonary disease, cancer or uncontrolled diabetes
• HIV or other immune-deficient state including subject on immunosuppressant therapies
• Deficiency limiting ability to perform an objective functional assessment of the operative knee or an inability to adhere to a post-operative rehabilitation protocol