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The purpose of this study is to evaluate the long-term outcomes of DeNovo NT, a tissue product used for the repair of cartilage damage in the knee. This product has been on the market since 2007 and implanted in more than 10,000 patients around the country.
Knee cartilage injury is a major cause of pain and functional impairment in young to middle age adults, and can lead to progressive joint degeneration. Adult cartilage has little regenerative capacity and many of the current treatment options have limited or unknown durability. DeNovo NT is an allogeneic tissue graft, prepared from donated juvenile cartilage, which has been shown to have a higher chondrogenic potential than adult cartilage. The graft involves a single surgery with no need for scaffolds, flaps or donor-site morbidity. This study will follow the long-term outcomes and durability of DeNovo NT in patients grafted with this product in the knee, for up to five years. It will enroll subjects prospectively (at the time of surgery) and retrospectively (those who have been previously implanted). Data will be collected on patient-reported outcomes, results of knee examinations, and reoperations and revisions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DeNovo NT patient | Patients who have received or who are scheduled to receive a DeNovo NT graft for repair of 1-2 knee cartilage lesions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DeNovo NT, Natural Tissue Graft | Other | DeNovo NT Natural Tissue Graft of 1 or 2 lesions up to 5 cm squared in area. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean scores from patient-reported clinical outcome surveys | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of reoperations and revision surgeries | 5 Years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients being recommended for arthroscopic or surgical intervention for articular cartilage lesionis of the knee
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Specialized Orthopaedic Surgery & Spine Center | Huntsville | Alabama | 35802 | United States | ||
| Naval Medical Center San Diego |
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| San Diego |
| California |
| 92134 |
| United States |
| Colorado Orthopedic Consultants | Aurora | Colorado | 80012 | United States |
| Emory University | Atlanta | Georgia | 30329 | United States |
| Midwest Orthopaedics at Rush Univ Hospital | Chicago | Illinois | 60612 | United States |
| OrthoIndy | Greenwood | Indiana | 46143 | United States |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | United States |
| New Mexico Orthopaedic Associates | Albuquerque | New Mexico | 87106 | United States |
| OrthoCarolina Research Institute | Charlotte | North Carolina | 28207 | United States |
| Specialized Orthopaedics & Sports Medicine | Columbus | Ohio | 43215 | United States |
| Cleveland Clinic Sports Health Center | Garfield Heights | Ohio | 44125 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| Jordan Young Institute | Virginia Beach | Virginia | 23462 | United States |
| Aurora Baycare Medical Center | Green Bay | Wisconsin | 54308 | United States |
| Dean Clinic | Madison | Wisconsin | 53715 | United States |
| ID | Term |
|---|---|
| D010008 | Osteochondritis Dissecans |
| ID | Term |
|---|---|
| D010007 | Osteochondritis |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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