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.
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.
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.
Single group
osteochondral transplant on the femoral condyle
Procedure/SurgeryPatients 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 0.9-8.0 cm2 in size, and cystic changes requiring osseous repair, as confirmed by MRI , CT scan, or arthroscopy and will undergo a osteochondral transplant by removing the damaged cartilage and replacing that cartilage with a cryopreserved osteochondral allograft core.
International Knee Documentation Committee (IKDC) score
Change of physical functioning and pain from baseline as assessed by the subjective International Knee Documentation Committee (IKDC) score. Scores are reported on a 0-100 scale, with low scores indicating worse outcomes and higher scores indicating better outcomes.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Change from baseline (pre-operative) Scores are reported on a 0-100 scale, with low scores indicating worse outcomes and higher scores indicating better outcomes.
Assessment of repair cartilage structure
Assessment of repair cartilage structure, using Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scores, as measured by Magnetic Resonance Imaging (MRI). Scores are reported on a 0-100 scale, with low scores indicating worse outcomes and higher scores indicating better outcomes.
Graft incorporation
Assessment of graft incorporation using Magnetic Resonance Imaging (MRI)
12-item Veterans RAND (VR-12)
Change from baseline (pre-operative) The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items are summarized into two scores, a "Physical Health Summary Measure" and a "Mental Health Summary Measure."
