Study of the Treatment of Articular Repair (STAR)

Articular Cartilage Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00158613
• Other study ID #: CARTCEL 012-99
• Status: Completed
• Phase: Phase 4
• Start date: March 2000
• Est. completion date: November 2005

Study information

• Verified date: May 2021
• Source: Vericel Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Articular Cartilage

Intervention

Biological:
• Carticel (autologous cultured chondrocyte) implantation
Each Carticel vial of autologous cultured chondrocytes contains approximately 12 million cells implanted into the defect and secured with a periosteal flap

Locations

Country	Name	City	State
Canada	Fowler Kennedy Sports Medicine Clinic	London	Ontario
Canada	Royal Columbian Hospital	New Westminster	British Columbia
Canada	St. Boniface General Hospital	Winnipeg	Manitoba
United States	Atlanta Sports Medicine & Orthopaedic Center	Atlanta	Georgia
United States	Beaumont Bone and Joint	Beaumont	Texas
United States	National Naval Medical Center	Bethesda	Maryland
United States	Children's Hospital	Boston	Massachusetts
United States	Pro Sports Orthopedics	Brookline	Massachusetts
United States	Physician's Clinic of Iowa	Cedar Rapids	Iowa
United States	Midwest Orthopedics	Chicago	Illinois
United States	Washington Orthopedic & Knee Clinic	Clinton	Maryland
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	Brooke Army Medical Center, Fort Sam	Houston	Texas
United States	Orthopaedics Indianapolis	Indianapolis	Indiana
United States	Bluegrass Orthopaedics	Lexington	Kentucky
United States	Denver/Vail Orthopedics	Lone Tree	Colorado
United States	Kerlan Jobe Orthopaedic Clinic	Los Angeles	California
United States	University of Minnesota	Minneapolis	Minnesota
United States	Midwest Orthopaedic Center	Peoria	Illinois
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Naval Medical Center Portsmouth	Portsmouth	Virginia
United States	Advanced Orthopedic Center	Richmond	Virginia
United States	Strong Memorial Hospital, University of Rochester	Rochester	New York
United States	Naval Medical Center San Diego	San Diego	California
United States	Santa Monica Orthopedic Group	Santa Monica	California
United States	Office of Dr. Noah Weiss	Sonoma	California
United States	Northwest Orthopedic Specialists	Spokane	Washington
United States	Keller Army Hospital	West Point	New York

Sponsors (1)

Lead Sponsor	Collaborator
Vericel Corporation

Countries where clinical trial is conducted

United States,  Canada, 

References & 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: res — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in the KOOS		Baseline, 6 month, 12 months, 24 months, 36 months, 48 months
Secondary	Change from Baseline in the Modified Cincinnati Score		6mo, 12mo, 18mo, 24mo, 30mo, 36mo, 42mo, 48mo
Secondary	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
Secondary	Change from Baseline in the SF-36 Health Status Survey		12mo, 24mo, 36mo, 48mo