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The study was terminated early due to a change in business strategy at the sponsor, unrelated to any safety concerns with the medical device.
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Multi-center, prospective, concurrently controlled, non-randomized, double-blind (patient and assessor). Treatment of large chondral lesions in the knee with microfracture plus the Chondro-Gide® ACC is non-inferior to treatment of small chondral lesions treated with microfracture alone.
The study evaluates the investigational treatment for treating large chondral lesions of the knee to the control treatment of microfracture alone for treating small lesions.Eligible patients with a large lesion will be treated with microfracture plus the Chondro-Gide® ACC and compared to patients with small lesions that are treated with microfracture alone. Outcome measures to be assessed include patient reported outcomes and freedom from certain adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | Active Comparator | Patients with small chondral lesions of the knee |
|
| Investigational Group | Experimental | Patients with large chondral lesions of the knee |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microfracture | Procedure | Debridement of cartilage followed by placement of small holes in the effected area to fill the debrided area with marrow and cells. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients achieving composite clinical success (CCS) at 24 months follow-up, with CCS | The CCS is defined as a patient meeting all of the three following criteria:
| 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score | The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury. Calculate the mean score of the individual items of each subscale and divide by 4 (the highest possible score for a single answer option). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabiana Martinelli | Geistlich Pharma AG | Study Director |
| Kevin Plancher, MD | Plancher Orthopedics and Sports Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The MORE Foundation | Phoenix | Arizona | 85023 | United States | ||
| Orthopaedic Foundation |
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| Microfracture plus placement of Chondro-Gide® ACC | Device | Debridement of cartilage followed by placement of small holes in the effected area to fill the debrided area with marrow and cells, followed by affixing Chondro-Gide® with fibrin glue. |
|
| Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months |
| Magnetic Resonance Observation of Cartilage Score | Magnetic Resonance Image (MRI) will be obtain during the course of the study at 3 months and 24 months. MOCART 2.0 scoring will occur by independent assessment using the MOCART score. The score is a 9-part and 29-item scoring system, also resulting in a final cartilage repair tissue score between 0 and 100 points; 0 points represent the worst imaginable score, 100 points represent the best imaginable score. | 3 months, 24 months |
| Patient satisfaction |
| 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months |
| Tegner Activity Scale | The Tegner activity score is a one-item score that grades activity based on work and sports activities. Tegner activity level scale is a scale that aims to provide a standardized method of grading work and sporting activities. A scale of the highest level activity being 10 and the lowest being 0 | 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months |
| Employment status | Employment status will be collected as: Employed full-time, Employed part-time, Not employed due to knee problems, Not employed due to reasons other than knee problems. | Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months |
| EuroQol-5 Dimension (EQ-5D) | The EQ-5D measures as a descriptive system comprised of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. | Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months |
| Stamford |
| Connecticut |
| 06905 |
| United States |
| Emory Sports Medicine Complex | Johns Creek | Georgia | 30097 | United States |
| Fraser Orthopaedic Institute | New Westminster | British Columbia | V3L 0E4 | Canada |
| University of Calgary | Calgary | CGY | T2N5A1 | Canada |
| Hamilton Health Sciences | Hamilton | Ontario | L8N 3Z5 | Canada |
| St. Joseph's Healthcare Hamilton | Hamilton | Ontario | L8N 4A6 | Canada |
| Sunnybrook Research Institute (SRI) | Toronto | Ontario | M4N 3M5 | Canada |
| University of Toronto Orthopaedics | Toronto | TOR | M5S 1B2 | Canada |
| Gelenkzentrum Mittelrhein GmbH | Mayen | Mayen | 63 D-56727 | Germany |
| Regio Kliniken GmbH | Pinneberg | Schleswig-Holstein | 25421 | Germany |
| Universitätsklinikum Schleswig Holstein Campus Lübeck | Lübeck | Germany |
| Orthopädische Chirurgie München | München | 81369 | Germany |
| Sportklinik Ravensburg | Ravensburg | Germany |
| University Hospital Regensburg | Regensburg | Germany |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D002357 | Cartilage Diseases |
| D015775 | Fractures, Stress |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D050723 | Fractures, Bone |
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| ID | Term |
|---|---|
| D054544 | Arthroplasty, Subchondral |
| ID | Term |
|---|---|
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
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