The purpose of this clinical study is to evaluate the use of ProChondrix Cryopreserved Osteochondral Allograft to obtain evidence of effectiveness, defined as an improvement in physical function and pain, when used on a symptomatic cartilage defect on the femoral condyle or patella in a mechanically stable knee.
This clinical study will use a multi-center, prospective design, to evaluate ProChondrix CR in approximately 80 patients who are scheduled to undergo treatment of a cartilage defect on the femoral condyle or patella.Patient follow-up will include a period of 60 months after surgery. During this follow-up period, each patient will be evaluated seven (7) times at: 3, 6, 12, 24, 36, 48 and 60 months after surgical intervention.
Study Type
OBSERVATIONAL
Enrollment
34
This tissue is a laser-etched, cryopreserved fresh osteochondral allograft that was developed as a single-stage alternative for articular cartilage restoration.
Midwest Orthopaedics at Rush
Chicago, Illinois, United States
University of Kentucky Research Foundation
Lexington, Kentucky, United States
Beacon Orthopaedics & Sports Medicine
Cincinnati, Ohio, United States
Subjective International Knee Documentation Committee (IKDC) Score
Change in physical pain and function as assessed by IKDC score from baseline to 60 months post-surgery
Time frame: Baseline, 3, 6, 12, 24, 36, 48 and 60 months
Knee injury and Osteoarthritis Outcome Score (KOOS)
Change of physical pain as assessed by KOOS score from baseline to 60 months post-surgery
Time frame: Baseline, 3, 6, 12, 24, 36, 48 and 60 months
SF-12 survey
Change in functional health and well-being as assessed by SF-12 survey from baseline to 60 months post-surgery
Time frame: Baseline, 3, 6, 12, 24, 36, 48 and 60 months
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Scores
Assessment of repair cartilage structure
Time frame: 12, 24 and 60 months
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