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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryopreserved Osteochondral Allograft | Procedure | This tissue is a laser-etched, cryopreserved fresh osteochondral allograft that was developed as a single-stage alternative for articular cartilage restoration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 3, 6, 12, 24, 36, 48 and 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Knee injury and Osteoarthritis Outcome Score (KOOS) | Change of physical pain as assessed by KOOS score from baseline to 60 months post-surgery | Baseline, 3, 6, 12, 24, 36, 48 and 60 months |
| SF-12 survey |
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Inclusion Criteria:
Exclusion Criteria:
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Skeletally mature patients between the ages of ≥18 and ≤ 60 who have a symptomatic cartilage defect (Grade 3 or 4) on the femoral condyle or patella, in a mechanically stable knee, or is being mechanically stabilized in the same procedure, between ≥ 1 cm2 and ≤ 5 cm2, measured as a rectangle length x width, as confirmed by MRI or arthroscopy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Midwest Orthopaedics at Rush | Chicago | Illinois | 60612 | United States | ||
| University of Kentucky Research Foundation |
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Change in functional health and well-being as assessed by SF-12 survey from baseline to 60 months post-surgery
| Baseline, 3, 6, 12, 24, 36, 48 and 60 months |
| Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Scores | Assessment of repair cartilage structure | 12, 24 and 60 months |
| Lexington |
| Kentucky |
| 40506 |
| United States |
| Beacon Orthopaedics & Sports Medicine | Cincinnati | Ohio | 45247 | United States |