Evaluating Cryopreserved Osteochondral Allograft Cores for the Treatment of Osteochondral Lesions in the Knee

Eligibility Criteria

• * Patient is ≥12 years and ≤ 60 years of age at the time of surgery.
• * Symptomatic patient presenting with moderate to severe pain in the index knee - unresponsive to conservative treatment (i.e., medication, bracing, physical therapy) and/or previous surgical intervention OR unsalvageable lesion that requires transplantation at the discretion of the treating physician.
• * Radiographically diagnosed, by MRI, or through arthroscopy, to have a cartilage defect on the femoral condyle between 2.0-8.0 cm2 in size.
• * Will be having an osteochondral transplant procedure.
• * Has a mechanically stable knee or can be mechanically stabilized in the same procedure.
• * Has a normally aligned knee as confirmed by anatomic comparison to contralateral limb, or \<5° varus or valgus malalignment that has been corrected or will be corrected in same procedure.
• * Ipsilateral knee compartment has intact menisci or requires partial meniscectomy ≤ 50% resulting in stable menisci.
• * MRI or CT scan obtained pre-operatively within 90 days of surgery.
• * Willingness to follow standardized rehabilitation procedures.
• * Has the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.
• * Bipolar articular cartilage involvement (kissing lesions) of the ipsilateral compartment (i.e., \> than ICRS Grade 2 on the opposing articular surface).
• * Cystic changes present in the underlying subchondral bone \>12 mm requiring osseous repair.
• * Has had a prior osteochondral allograft transplant procedure in the same knee.
• * Will be receiving a meniscus allograft transplantation in the same procedure.
• * Body Mass Index (BMI)of ≥ 35 kg/m2.
• * Active malignancy: undergoing treatment for tumor or boney traumatic injury or a history of any invasive malignancy (except non-melanoma skin cancer) unless the patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years.
• * Clinical and/or radiographic disease in the affected joint that includes generalized osteoarthritis, gout or a history of gout or pseudo-gout.
• * Active local microbial infection or a systemic infection, including prior or pending treatment for HIV, syphilis, Hepatitis B or Hepatitis C.
• * Currently immunologically suppressed or immunocompromised, or a medical condition requiring radiation and/or chemotherapy.
• * Unstable cardiovascular, renal, hepatic, endocrine and/or pulmonary disease, cancer, or uncontrolled diabetes.
• * Has a history of any inflammatory joint arthropathy.
• * Currently using/chronic on oral corticosteroids.
• * Received interarticular corticosteroid injection ≤ 90 days prior to surgery
• * Received hyaluronic acid injections into the joint space ≤ 45 days prior to surgery.
• * Is a female patient who is pregnant.
• * Physically or mentally compromised (i.e., being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease) in a manner that would compromise his/her ability to participate in the clinical study.
• * Has a history of substance abuse- (including but not limited to recreational drugs, alcohol) or has been treated in the last 6 months before enrollment for alcohol and/or drug abuse in an inpatient substance abuse program.
• * Patients who, in the opinion of the Investigator, would not be able or willing to comply with the protocol.
• * Is currently involved in a study of another investigational product for similar purpose or has been in the previous 90 days.
• * Has any contraindications for MRI.
• * Is having the procedure as part of a Worker's Compensation claim.
• * Is a ward of the state, prisoner, or transient.