Study of the Treatment of Articular Repair (STAR)
- Conditions
- Articular Cartilage
- Registration Number
- NCT00158613
- Lead Sponsor
- Vericel Corporation
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
- Provided written informed consent
- Documented history of at least one Grade III or Grade IV defect (modified Outerbridge classification) on the medial or lateral femoral condyle or trochlea
- Failed prior treatment for articular cartilage defects of the knee, e.g. inadequate response to a non- ACI surgical procedure to treat the lesion, within past 3 yrs
- Patient reported overall knee condition of 5 or less on the Modified Cinn Rating System
- patients must have had a cartilage defect located on the medial or lateral femoral condyle or trochlea which had an inadequate response to a prior arthroscopic or other non-Carticel surgical repair procedure
- see above
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Mean change from baseline in the KOOS Baseline, 6 month, 12 months, 24 months, 36 months, 48 months
- Secondary Outcome Measures
Name Time Method 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 12mo, 24mo, 36mo, 48mo Change from Baseline in the SF-36 Health Status Survey 12mo, 24mo, 36mo, 48mo
Trial Locations
- Locations (28)
Royal Columbian Hospital
🇨🇦New Westminster, British Columbia, Canada
Kerlan Jobe Orthopaedic Clinic
🇺🇸Los Angeles, California, United States
Orthopaedics Indianapolis
🇺🇸Indianapolis, Indiana, United States
Brooke Army Medical Center, Fort Sam
🇺🇸Houston, Texas, United States
Santa Monica Orthopedic Group
🇺🇸Santa Monica, California, United States
Naval Medical Center San Diego
🇺🇸San Diego, California, United States
Office of Dr. Noah Weiss
🇺🇸Sonoma, California, United States
Midwest Orthopaedic Center
🇺🇸Peoria, Illinois, United States
Midwest Orthopedics
🇺🇸Chicago, Illinois, United States
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Atlanta Sports Medicine & Orthopaedic Center
🇺🇸Atlanta, Georgia, United States
Physician's Clinic of Iowa
🇺🇸Cedar Rapids, Iowa, United States
National Naval Medical Center
🇺🇸Bethesda, Maryland, United States
Bluegrass Orthopaedics
🇺🇸Lexington, Kentucky, United States
Washington Orthopedic & Knee Clinic
🇺🇸Clinton, Maryland, United States
Children's Hospital
🇺🇸Boston, Massachusetts, United States
Pro Sports Orthopedics
🇺🇸Brookline, Massachusetts, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Keller Army Hospital
🇺🇸West Point, New York, United States
Strong Memorial Hospital, University of Rochester
🇺🇸Rochester, New York, United States
Beaumont Bone and Joint
🇺🇸Beaumont, Texas, United States
Advanced Orthopedic Center
🇺🇸Richmond, Virginia, United States
Naval Medical Center Portsmouth
🇺🇸Portsmouth, Virginia, United States
Northwest Orthopedic Specialists
🇺🇸Spokane, Washington, United States
St. Boniface General Hospital
🇨🇦Winnipeg, Manitoba, Canada
Fowler Kennedy Sports Medicine Clinic
🇨🇦London, Ontario, Canada
Denver/Vail Orthopedics
🇺🇸Lone Tree, Colorado, United States