Study of the Treatment of Articular Repair (STAR) - Full Text View

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	Biological: Carticel (autologous cultured chondrocyte) implantation	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Prospective, Longitudinal Within-Patient Evaluation of the Effectiveness (Durability) of Carticel® (Autologous Cultured Chondrocytes) Compared to Non-Carticel Surgical Treatment for Articular Cartilage Defects of the Knee.

Further study details as provided by Genzyme:

Primary Outcome Measures:

Mean change from baseline in the KOOS [ Time Frame: Baseline, 6 month, 12 months, 24 months, 36 months, 48 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from Baseline in the Modified Cincinnati Score [ Time Frame: 6mo, 12mo, 18mo, 24mo, 30mo, 36mo, 42mo, 48mo ] [ Designated as safety issue: No ]
Change from Baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS)Which consists of five sub- categories = Pain, ADL, QOL, Symptoms, Sport [ Time Frame: 12mo, 24mo, 36mo, 48mo ] [ Designated as safety issue: No ]
Change from Baseline in the SF-36 Health Status Survey [ Time Frame: 12mo, 24mo, 36mo, 48mo ] [ Designated as safety issue: No ]

Enrollment:	126
Study Start Date:	March 2000
Study Completion Date:	November 2005
Primary Completion Date:	November 2005 (Final data collection date for primary outcome measure)

Intervention Details:

Each Carticel vial of autologous cultured chondrocytes contains approximately 12 million cells implanted into the defect and secured with a periosteal flap

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

see above

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158613

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Locations

United States, California
Kerlan Jobe Orthopaedic Clinic
Los Angeles, California, United States, 90045
Naval Medical Center San Diego
San Diego, California, United States, 92134
Santa Monica Orthopedic Group
Santa Monica, California, United States, 90404
Office of Dr. Noah Weiss
Sonoma, California, United States, 95476
United States, Colorado
Denver/Vail Orthopedics
Lone Tree, Colorado, United States, 80124
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06034
United States, Georgia
Atlanta Sports Medicine & Orthopaedic Center
Atlanta, Georgia, United States, 30327
United States, Illinois
Midwest Orthopedics
Chicago, Illinois, United States, 60612
Midwest Orthopaedic Center
Peoria, Illinois, United States, 61602
United States, Indiana
Orthopaedics Indianapolis
Indianapolis, Indiana, United States, 46237
United States, Iowa
Physician's Clinic of Iowa
Cedar Rapids, Iowa, United States, 52401
United States, Kentucky
Bluegrass Orthopaedics
Lexington, Kentucky, United States, 40509
United States, Maryland
National Naval Medical Center
Bethesda, Maryland, United States, 20889
Washington Orthopedic & Knee Clinic
Clinton, Maryland, United States, 20735
United States, Massachusetts
Children's Hospital
Boston, Massachusetts, United States, 02115
Pro Sports Orthopedics
Brookline, Massachusetts, United States, 02445
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55454
United States, New York
Strong Memorial Hospital, University of Rochester
Rochester, New York, United States, 14642
Keller Army Hospital
West Point, New York, United States, 10996
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Beaumont Bone and Joint
Beaumont, Texas, United States, 77707
Brooke Army Medical Center, Fort Sam
Houston, Texas, United States, 78234
United States, Virginia
Naval Medical Center Portsmouth
Portsmouth, Virginia, United States, 23708
Advanced Orthopedic Center
Richmond, Virginia, United States, 23294
United States, Washington
Northwest Orthopedic Specialists
Spokane, Washington, United States, 99204
Canada, British Columbia
Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3L 3W7
Canada, Manitoba
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Ontario
Fowler Kennedy Sports Medicine Clinic
London, Ontario, Canada, N6A 3K7

Sponsors and Collaborators

Genzyme

Investigators

Study Director:

Medical Monitor

Genzyme

More Information

Publications:

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. Epub 2008 Oct 16.

Responsible Party:	Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier:	NCT00158613 History of Changes
Other Study ID Numbers:	CARTCEL 012-99
Study First Received:	September 8, 2005
Last Updated:	July 28, 2009
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 16, 2013