| ID | Type | Description | Link |
|---|---|---|---|
| IDE # 11803 | Other Identifier | FDA |
Not provided
Not provided
Study was terminated because of very low enrollment rate.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The Cartilage Autograft Implantation System (CAIS) is designed as a single surgical treatment of damaged knee cartilage using the subject's own healthy cartilage obtained from a non-weight or low weight-bearing region. CAIS is indicated for the repair of articular cartilage lesions and osteochondritis dissecans (OCD) of the knee through cartilage regeneration.
The Cartilage Autograft Implantation System (CAIS) is a kit of devices that utilizes morselized autologous hyaline cartilage harvested arthroscopically, affixed onto a synthetic, resorbable implant using a fibrin sealant and implanted in a single surgical procedure. The system is designed as a surgical treatment of damaged knee cartilage using the subject's own healthy cartilage obtained from a non-weight or low weight-bearing region.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Randomized to Microfracture |
|
| 2 | Experimental | Randomized to Device |
|
| 3 | Experimental | Non-randomized with lesion greater than 6cmˆ2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microfracture | Procedure | The microfracture procedure is a standard method for treatment of cartilage damage in which the surgeon will clean the site of your cartilage damage and then will make several small holes in your bone to stimulate your bone marrow with the intention to repair the damaged area with new cartilage tissue |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety and efficacy of CAIS compared to microfracture at 24 months post-treatment, with the primary efficacy assessment based on an analysis of superiority of CAIS to microfracture for reduction in knee pain and improvement in function | 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety of CAIS through 48 months | 48 Months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brooks Story, PhD | DePuy Synthes Mitek Sports Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson Orthopaedic Institute | Tucson | Arizona | 85712 | United States | ||
| MWMC Bentonville Hospital |
These data will not be used in support of an FDA submission, and the product will not be commercialized. As such, there is no plan to share the IPD.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Cartilage Autograft Implantation System | Device | A surgical treatment of damaged knee cartilage using the subject's own healthy cartilage obtained from a non-weight or low weight-bearing region |
|
| Bentonville |
| Arkansas |
| 72712 |
| United States |
| CORE Orthopaedic Medical Center | Encinitas | California | 92024 | United States |
| Santa Monica Orthopaedic Group | Santa Monica | California | 90404 | United States |
| Southern California Orthopaedic Group | Van Nuys | California | 91405 | United States |
| JDP Medical Research, LLC | Denver | Colorado | 80014 | United States |
| Shrock Orthopedic Research | Fort Lauderdale | Florida | 33316 | United States |
| Andrews Institute | Gulf Breeze | Florida | 32561 | United States |
| Florida Orthopaedics Institute and Research Foundation | Tampa | Florida | 33637 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| OrthoIndy | Indianapolis | Indiana | 46237 | United States |
| University of Kentucky Medical Center | Lexington | Kentucky | 40536-0284 | United States |
| Harvard Vanguard / New England Baptist Hospital | Chestnut Hill | Massachusetts | 02467 | United States |
| UMass Medical Center - Orthopedic Research | Worcester | Massachusetts | 01655 | United States |
| TRIA Orthopaedic Center | Bloomington | Minnesota | 55431 | United States |
| University of Missouri | Columbia | Missouri | 65211 | United States |
| Rothman Institute | Egg Harbor | New Jersey | 08234 | United States |
| University Orthopaedic Group LLC | New Brunswick | New Jersey | 08901 | United States |
| New York University School of Medicine | New York | New York | 10003 | United States |
| University of Rochester Medical Center | Rochester | New York | 14618 | United States |
| Orlin & Cohen Orthopedic Group | Rockville Centre | New York | 11570 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Orthopaedic Research Foundation of the Carolinas | Greenville | South Carolina | 29615 | United States |
| OrthoMemphis, PC | Memphis | Tennessee | 38120 | United States |
| Basin Orthopedic Surgical Specialists | Odessa | Texas | 79761 | United States |
| Richmond Bone & Joint Clinic, P.A. | Sugar Land | Texas | 77478 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Royal Columbian Hospital | New West Minster | British Columbia | V3L 5P5 | Canada |
| Fowler Kennedy Sports Medicine Clinic | New West Minister | Ontario | N6A 3K7 | Canada |
| ID | Term |
|---|---|
| D010008 | Osteochondritis Dissecans |
| ID | Term |
|---|---|
| D010007 | Osteochondritis |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D054544 | Arthroplasty, Subchondral |
| ID | Term |
|---|---|
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
Not provided
Not provided