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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-60
SponsorAlloSource

About this trial

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.

Eligibility criteria

Qualifiers

Patients are ≥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 CT scans, or through arthroscopy, to have a cartilage defect on the femoral condyle between 0.9-8.0 cm2 in size.

Will be having an osteochondral transplant procedure.

Disqualifiers

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

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.

Trial design

Treatments tested in this trial

  • osteochondral transplant on the femoral condyle

Treatment groups

68 Participants
are divided into 1 treatment group

Sponsors and collaborators