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

Inclusion 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 requirestransplantation at the discretion of the treating physician.

• Radiographically diagnosed, by MRI, or through arthroscopy, to have a cartilagedefect 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 sameprocedure.

• Has a normally aligned knee as confirmed by anatomic comparison to contralaterallimb, or <5° varus or valgus malalignment that has been corrected or will becorrected 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 writteninformed consent, and to comply with the study protocol.

Exclusion Criteria:

• Bipolar articular cartilage involvement (kissing lesions) of the ipsilateralcompartment (i.e., > than ICRS Grade 2 on the opposing articular surface).

• Cystic changes present in the underlying subchondral bone >12 mm requiring osseousrepair.

• 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 ahistory of any invasive malignancy (except non-melanoma skin cancer) unless thepatient has been treated with curative intent and there have been no clinical signsor symptoms of the malignancy for at least 5 years.

• Clinical and/or radiographic disease in the affected joint that includes generalizedosteoarthritis, gout or a history of gout or pseudo-gout.

• Active local microbial infection or a systemic infection, including prior or pendingtreatment for HIV, syphilis, Hepatitis B or Hepatitis C.

• Currently immunologically suppressed or immunocompromised, or a medical conditionrequiring 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 psychiatricdisorder, senile dementia, Alzheimer's disease) in a manner that would compromisehis/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 alcoholand/or drug abuse in an inpatient substance abuse program.

• Patients who, in the opinion of the Investigator, would not be able or willing tocomply with the protocol.

• Is currently involved in a study of another investigational product for similarpurpose 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.