Study of the Treatment of Articular Repair (STAR)

Phase 4

Completed

• 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

Study Timeline

• Study Start: 2000-03
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-12
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-10
• Last Update Posted: 2021-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

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)

Kerlan Jobe Orthopaedic Clinic; 🇺🇸 Los Angeles, California, 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

Denver/Vail Orthopedics; 🇺🇸 Lone Tree, Colorado, United States

University of Connecticut Health Center; 🇺🇸 Farmington, Connecticut, United States

Atlanta Sports Medicine & Orthopaedic Center; 🇺🇸 Atlanta, Georgia, United States

Midwest Orthopedics; 🇺🇸 Chicago, Illinois, United States

Midwest Orthopaedic Center; 🇺🇸 Peoria, Illinois, United States

Orthopaedics Indianapolis; 🇺🇸 Indianapolis, Indiana, United States

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