Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is to compare NOVOCART 3D relative to Microfracture for the treatment of knee cartilage defects. Efficacy will be evaluated by both pain and function. Safety will also be evaluated.
Subjects with articular knee defects will be randomized to receive either Microfracture or NOVOCART 3D. Subjects will be followed for five years in total and will be evaluated for safety and efficacy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NOVOCART 3D | Experimental | Scaffold assisted autologous chondrocyte Implant |
|
| Microfracture | Active Comparator | considered a typical treatment for articular cartilage repair |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microfracture | Procedure | Surgical procedure which creates a marrow clot in the prepare cartilage defect. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Knee injury and Osteoarthritis Outcome Score (KOOS) - Pain Subdomain | As measured by a change in KOOS (pain subdomain) score at 24 months from baseline | 24 months post treatment |
| Knee injury and Osteoarthritis Outcome Score (KOOS) - Function Subdomain | As measured by a change in KOOS score (activity of daily living subdomain) at 24 months from baseline | 24 months post treatment |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert Spiro, PhD | Octane Biotherapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grossmont Orthopaedic Medical Group | La Mesa | California | 91942 | United States | ||
| UCLA |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| NOVOCART 3D | Biological | combination product- biologic (autologous chondrocytes) /device (scaffold) implant |
|
| Los Angeles |
| California |
| 90095 |
| United States |
| Stanford Medicine | Redwood City | California | 94063 | United States |
| Cu Sports Medicine | Denver | Colorado | 80222 | United States |
| Yampa Valley Medical Center | Steamboat Springs | Colorado | 80487 | United States |
| Tenet Florida Physician Services | Boca Raton | Florida | 33433 | United States |
| Paley Orthopedic and Spine Institute | West Palm Beach | Florida | 33407 | United States |
| Saint Alphonsus Medical Group | Meridian | Idaho | 83642 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Northshore University Health System | Evanston | Illinois | 60201 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| Ochsner Health System | New Orleans | Louisiana | 70121 | United States |
| University of Michigan | Ann Arbor | Michigan | 48106 | United States |
| Tria Orthopaedic Center | Bloomington | Minnesota | 55431 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| University of Missouri Healthcare | Columbia | Missouri | 65212 | United States |
| Mount Sinai Faculty Practice Associates | New York | New York | 10029 | United States |
| Plancher Orthopaedics & Sports Medicine | New York | New York | 10128 | United States |
| Long Island Bone and Joint Llp | Port Jefferson | New York | 11777 | United States |
| Ohio State University Sports Medicine | Columbus | Ohio | 43221 | United States |
| Tulsa Bone and Joint Associates | Tulsa | Oklahoma | 74146 | United States |
| St. Luke'S University Health Network | Bethlehem | Pennsylvania | 18015 | United States |
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Allegheny - Singer Research Institute | Pittsburgh | Pennsylvania | 15212 | United States |
| Clinical Research Solutions | Jackson | Tennessee | 38305 | United States |
| Alpine Orthopaedics | North Logan | Utah | 84341 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| The Orthopaedic Center of Central Virginia Inc | Lynchburg | Virginia | 24501 | United States |
| Advanced Orthopaedics | Richmond | Virginia | 23294 | United States |
| University of Alberta | Edmonton | Alberta | T6G 2R3 | Canada |
| Simon Fraser Orthopaedic Fund | Surrey | British Columbia | V3T 0H1 | Canada |
| Dalhousie University | Halifax | Nova Scotia | B3H 2E1 | Canada |
| St. Josephs Healthcare Hamilton | Hamilton | Ontario | L8N 4A6 | Canada |
| Lawson Health Research Institute | London | Ontario | N6C 2R5 | Canada |
| ID | Term |
|---|---|
| D054544 | Arthroplasty, Subchondral |
| ID | Term |
|---|---|
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
Not provided
Not provided