Study of the Treatment of Articular Repair (STAR)

NCT00158613 | Completed Phase 4

• 1 other identifier: CARTCEL 012-99
• Study Type: interventional
• Target: 126
• Locations: 2 countries
• Sites: 28

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.

Conditions

Articular Cartilage

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in the KOOS

  Baseline, 6 month, 12 months, 24 months, 36 months, 48 months

Secondary Outcomes (3)

• 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

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• see above

Sponsors & Collaborators

• Vericel Corporation: lead

Study Sites (28)

Kerlan Jobe Orthopaedic Clinic

Los Angeles, California, 90045, United States

Location

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

Santa Monica Orthopedic Group

Santa Monica, California, 90404, United States

Location

Office of Dr. Noah Weiss

Sonoma, California, 95476, United States

Location

Denver/Vail Orthopedics

Lone Tree, Colorado, 80124, United States

Location

University of Connecticut Health Center

Farmington, Connecticut, 06034, United States

Location

Atlanta Sports Medicine & Orthopaedic Center

Atlanta, Georgia, 30327, United States

Location

Midwest Orthopedics

Chicago, Illinois, 60612, United States

Location

Midwest Orthopaedic Center

Peoria, Illinois, 61602, United States

Location

Orthopaedics Indianapolis

Indianapolis, Indiana, 46237, United States

Location

Physician's Clinic of Iowa

Cedar Rapids, Iowa, 52401, United States

Location

Bluegrass Orthopaedics

Lexington, Kentucky, 40509, United States

Location

National Naval Medical Center

Bethesda, Maryland, 20889, United States

Location

Washington Orthopedic & Knee Clinic

Clinton, Maryland, 20735, United States

Location

Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Pro Sports Orthopedics

Brookline, Massachusetts, 02445, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

Strong Memorial Hospital, University of Rochester

Rochester, New York, 14642, United States

Location

Keller Army Hospital

West Point, New York, 10996, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Beaumont Bone and Joint

Beaumont, Texas, 77707, United States

Location

Brooke Army Medical Center, Fort Sam

Houston, Texas, 78234, United States

Location

Naval Medical Center Portsmouth

Portsmouth, Virginia, 23708, United States

Location

Advanced Orthopedic Center

Richmond, Virginia, 23294, United States

Location

Northwest Orthopedic Specialists

Spokane, Washington, 99204, United States

Location

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Location

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Fowler Kennedy Sports Medicine Clinic

London, Ontario, N6A 3K7, Canada

Location

Related Publications (1)

• 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.

  PMID: 18927254 RESULT

MeSH Terms

Interventions

Drug Implants

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Medical Monitor

  Genzyme, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: March 1, 2000
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: May 11, 2021

Record last verified: 2021-05

Locations

US (25); CA (3)