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This study is a prospective, longitudinal, multi-center, within patient evaluation of patients with articular cartilage defects of the knee who have had an inadequate response to a prior non-Carticel surgical treatment. Patients who met eligibility criteria were enrolled in the study. Subsequent to implantation with Carticel patients have follow-up every 6-months up to 48-months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carticel (autologous cultured chondrocyte) implantation | Biological | Each Carticel vial of autologous cultured chondrocytes contains approximately 12 million cells implanted into the defect and secured with a periosteal flap |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in the KOOS | Baseline, 6 month, 12 months, 24 months, 36 months, 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Modified Cincinnati Score | 6mo, 12mo, 18mo, 24mo, 30mo, 36mo, 42mo, 48mo | |
| Change from Baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS)Which consists of five sub- categories = Pain, ADL, QOL, Symptoms, Sport |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kerlan Jobe Orthopaedic Clinic | Los Angeles | California | 90045 | United States | ||
| Naval Medical Center San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18927254 | Result | Zaslav K, Cole B, Brewster R, DeBerardino T, Farr J, Fowler P, Nissen C; STAR Study Principal Investigators. A prospective study of autologous chondrocyte implantation in patients with failed prior treatment for articular cartilage defect of the knee: results of the Study of the Treatment of Articular Repair (STAR) clinical trial. Am J Sports Med. 2009 Jan;37(1):42-55. doi: 10.1177/0363546508322897. Epub 2008 Oct 16. |
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| 12mo, 24mo, 36mo, 48mo |
| Change from Baseline in the SF-36 Health Status Survey | 12mo, 24mo, 36mo, 48mo |
| San Diego |
| California |
| 92134 |
| United States |
| Santa Monica Orthopedic Group | Santa Monica | California | 90404 | United States |
| Office of Dr. Noah Weiss | Sonoma | California | 95476 | United States |
| Denver/Vail Orthopedics | Lone Tree | Colorado | 80124 | United States |
| University of Connecticut Health Center | Farmington | Connecticut | 06034 | United States |
| Atlanta Sports Medicine & Orthopaedic Center | Atlanta | Georgia | 30327 | United States |
| Midwest Orthopedics | Chicago | Illinois | 60612 | United States |
| Midwest Orthopaedic Center | Peoria | Illinois | 61602 | United States |
| Orthopaedics Indianapolis | Indianapolis | Indiana | 46237 | United States |
| Physician's Clinic of Iowa | Cedar Rapids | Iowa | 52401 | United States |
| Bluegrass Orthopaedics | Lexington | Kentucky | 40509 | United States |
| National Naval Medical Center | Bethesda | Maryland | 20889 | United States |
| Washington Orthopedic & Knee Clinic | Clinton | Maryland | 20735 | United States |
| Children's Hospital | Boston | Massachusetts | 02115 | United States |
| Pro Sports Orthopedics | Brookline | Massachusetts | 02445 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55454 | United States |
| Strong Memorial Hospital, University of Rochester | Rochester | New York | 14642 | United States |
| Keller Army Hospital | West Point | New York | 10996 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Beaumont Bone and Joint | Beaumont | Texas | 77707 | United States |
| Brooke Army Medical Center, Fort Sam | Houston | Texas | 78234 | United States |
| Naval Medical Center Portsmouth | Portsmouth | Virginia | 23708 | United States |
| Advanced Orthopedic Center | Richmond | Virginia | 23294 | United States |
| Northwest Orthopedic Specialists | Spokane | Washington | 99204 | United States |
| Royal Columbian Hospital | New Westminster | British Columbia | V3L 3W7 | Canada |
| St. Boniface General Hospital | Winnipeg | Manitoba | R2H 2A6 | Canada |
| Fowler Kennedy Sports Medicine Clinic | London | Ontario | N6A 3K7 | Canada |
| ID | Term |
|---|---|
| D004343 | Drug Implants |
| ID | Term |
|---|---|
| D003692 | Delayed-Action Preparations |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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