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 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 undergoing an osteochondral transplant procedure will be eligible for enrollment. Patients will receive one or more cryopreserved osteochondral allograft core transplants to replace damaged cartilage. Patients will be followed for up to 60 months post-procedure (6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months) to evaluate short and long-term outcomes of the procedure using the cryopreserved osteochondral allograft cores.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
68
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 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.
Banner- University Medical Center- Phoenix Orthopedic and Sports Medicine Institute
Phoenix, Arizona, United States
RECRUITINGCedars-Sinai Kerlan Jobe Institute
Los Angeles, California, United States
NOT_YET_RECRUITINGStanford Medicine-Orthopaedics and Sports Medicine in Redwood City
Redwood City, California, United States
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.
Time frame: 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months post procedure
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.
Time frame: 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
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.
Time frame: 12 months, 24 months and 60 months post procedure
Graft incorporation
Assessment of graft incorporation using Magnetic Resonance Imaging (MRI)
Time frame: 12 months, 24 months and 60 months post procedure
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."
Time frame: 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months post procedure
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University of California San Francisco
San Francisco, California, United States
RECRUITINGRush Copley Medical Center
Aurora, Illinois, United States
RECRUITINGUniversity of Kentucky Research Foundation
Lexington, Kentucky, United States
RECRUITINGRevision surgery
Incidences of revision surgeries during study follow up time period
Time frame: 60 months post-procedure