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company dissolution
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This confirmatory study is a prospective randomized trial comparing the efficacy and safety of an autologous chondrocyte tissue implant (NeoCart) to the surgical intervention microfracture in the treatment of cartilage defects in the knee.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NeoCart | Experimental | Autologous cartilagenous tissue implant |
|
| Microfracture | Active Comparator | surgical intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeoCart | Biological | implantation of an cartilagenous tissue implant derived from the patients own cells. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change of physical functioning and pain as assessed by patient reported outcome measures (Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) score) | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Repair cartilage structure as measured by magnetic resonance imaging (MRI) | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Belschner | Histogenics Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson Orthopaedic Institute | Tucson | Arizona | 85712 | United States | ||
| Grossmont Orthopedic Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22637204 | Background | Crawford DC, DeBerardino TM, Williams RJ 3rd. NeoCart, an autologous cartilage tissue implant, compared with microfracture for treatment of distal femoral cartilage lesions: an FDA phase-II prospective, randomized clinical trial after two years. J Bone Joint Surg Am. 2012 Jun 6;94(11):979-89. doi: 10.2106/JBJS.K.00533. | |
| 19448048 |
| Label | URL |
|---|---|
| Histogenics WebSite | View source |
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| Microfracture | Procedure | holes are created in bone at the base of the defect bed to encourage growth of tissue within the defect bed. |
|
| La Mesa |
| California |
| 91942 |
| United States |
| Orthopaedic Specialty Institute/Newport Orthopedic Institute (OSI/NOI) | Orange | California | 92868 | United States |
| UCSF Mission Bay Orthopaedic Institute | San Francisco | California | 94158 | United States |
| Southern California Orthopedic Research and Education | Van Nuys | California | 91405 | United States |
| Colorado University Boulder | Boulder | Colorado | 80304 | United States |
| Steadman Hawkins Clinic - Denver | Denver | Colorado | 80111 | United States |
| Shrock Clinical Research | Fort Lauderdale | Florida | 33316 | United States |
| Jewett Orthopaedic Clinic | Orlando | Florida | 32822 | United States |
| Optim Healthcare | Savannah | Georgia | 31405 | United States |
| St. Lukes Medical Center | Boise | Idaho | 83702 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| OrthoIndy | Greenwood | Indiana | 46143 | United States |
| Ochsner Clinic Sports Medicine | New Orleans | Louisiana | 70121 | United States |
| Orthopaedic Associates | Portland | Maine | 04102 | United States |
| Harvard Vanguard Medical Associates | West Roxbury | Massachusetts | 02467 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| TRIA Orthopaedic Center | Bloomington | Minnesota | 55431 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Alpine Orthopedics & Sports Medicine | Bozeman | Montana | 59718 | United States |
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| Duke Sports Medicine | Durham | North Carolina | 27710 | United States |
| Ohio State University - Department of Sports Medicine | Columbus | Ohio | 43221 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| The San Antonio Orthopaedic Group (TSAOG) | San Antonio | Texas | 78216 | United States |
| The Orthopedic Specialty Hospital | Murray | Utah | 84107 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| Simon Fraser Orthopaedic Fund | New Westminster | British Columbia | Canada |
| Fowler Kennedy Sports Medicine Clinic | London | Ontario | Canada |
| Crawford DC, Heveran CM, Cannon WD Jr, Foo LF, Potter HG. An autologous cartilage tissue implant NeoCart for treatment of grade III chondral injury to the distal femur: prospective clinical safety trial at 2 years. Am J Sports Med. 2009 Jul;37(7):1334-43. doi: 10.1177/0363546509333011. Epub 2009 May 15. |
| ID | Term |
|---|---|
| D054544 | Arthroplasty, Subchondral |
| ID | Term |
|---|---|
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
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