A Prospective, Open Label, Single-Arm, Multi-Center Study Evaluating Cryopreserved Osteochondral Allograft Cores for the Treatment of Osteochondral Lesions in the Knee

The primary objective of this study is to obtain evidence of the effectiveness of Cryopreserved Osteochondral Allograft Core in the treatment of osteochondral lesions on the femoral condyle. This is a prospective evaluation of Cryopreserved Osteochondral Allograft Cores for the repair of osteochondral lesions on the femoral condyle. Patients between the ages of ≥12 years and ≤ 60 years who have a symptomatic full-thickness cartilage lesion (Grade 3 or 4) on the femoral condyle, in a mechanically stable knee, or is being mechanically stabilized in the same procedure, between 2.0-8.0 cm 2 in size, and cystic changes requiring osseous repair present in less than or equal to 12 mm subchondral bone, as confirmed by MRI , CT scan, or arthroscopy. Patients who will be undergoing an osteochondral transplant procedure will be eligible for enrollment in this study. Concomitant procedures can include meniscus repair or debridement (resulting in a functional meniscus), knee ligament repair or reconstruction, osteotomy, or hemi-epiphysiodesis, if appropriate.