CARTCEL01299: Study of the Treatment of Articular Repair (STAR)

This study has been completed.

Sponsored By:	Genzyme
Information Provided By:	Genzyme
ClinicalTrials.gov Identifier:	NCT00158613

Purpose

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.

Condition	Intervention	Phase
articular cartilage	Procedure: Carticel (autologous cultured chondrocyte) implantation	Phase IV

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Further Study Details:

Primary Outcomes: The time to treatment failure for the prior non-Carticel cartilage repair procedure compared to the time to treatment failure of Carticel

Total Enrollment: 155

Study Start: 2000-03; Study Completion: 2005-11

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

see above

Location Information

California
Santa Monica Orthopedic Group, Santa Monica, California, 90404, United States
Office of Dr. Noah Weiss, Sonoma, California, 95476, United States
Naval Medical Center San Diego, San Diego, California, 92134, United States
Kerlan Jobe Orthopaedic Clinic, Los Angeles, California, 90045, United States

Colorado
Denver/Vail Orthopedics, Lone Tree, Colorado, 80124, United States

Connecticut
University of Connecticut Health Center, Farmington, Connecticut, 06034, United States

Georgia
Atlanta Sports Medicine & Orthopaedic Center, Atlanta, Georgia, 30327, United States

Illinois
Midwest Orthopedics, Chicago, Illinois, 60612, United States
Midwest Orthopaedic Center, Peoria, Illinois, 61602, United States

Indiana
Orthopaedics Indianapolis, Indianapolis, Indiana, 46237, United States

Iowa
Physician's Clinic of Iowa, Cedar Rapids, Iowa, 52401, United States

Kentucky
Bluegrass Orthopaedics, Lexington, Kentucky, 40509, United States

Maryland
Washington Orthopedic & Knee Clinic, Clinton, Maryland, 20735, United States
National Naval Medical Center, Bethesda, Maryland, 20889, United States

Massachusetts

Children's Hospital, Boston, Massachusetts, 02115, United States
Pro Sports Orthopedics, Brookline, Massachusetts, 02445, United States

Minnesota
University of Minnesota, Minneapolis, Minnesota, 55454, United States

New York
Keller Army Hospital, West Point, New York, 10996, United States
Strong Memorial Hospital, University of Rochester, Rochester, New York, 14642, United States

Pennsylvania
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, 15232, United States

Texas
Brooke Army Medical Center, Fort Sam, Houston, Texas, 78234, United States
Beaumont Bone and Joint, Beaumont, Texas, 77707, United States

Virginia
Advanced Orthopedic Center, Richmond, Virginia, 23294, United States
Naval Medical Center Portsmouth, Portsmouth, Virginia, 23708, United States

Washington
Northwest Orthopedic Specialists, Spokane, Washington, 99204, United States

Canada, British Columbia
Royal Columbian Hospital, New Westminster, British Columbia, V3L 3W7, Canada

Canada, Manitoba
St. Boniface General Hospital, Winnipeg, Manitoba, R2H 2A6, Canada

Canada, Ontario
Fowler Kennedy Sports Medicine Clinic, London, Ontario, N6A 3K7, Canada

More Information

US FDA Approved Product Insert for Carticel®

/pdfs/carticel_pi.pdf

Study ID Numbers: CARTCEL 012-99
ClinicalTrials.gov Identifier: NCT00158613
Health Authority: United States: Institutional Review Board