Chondrofix Osteochondral Allograft Prospective Study

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