Study of the Treatment of Articular Repair (STAR)

Completed · Phase 4

Conditions studied: Articular Cartilage

In brief

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.

Key facts

Study ID

NCT00158613

Run by

Vericel Corporation

People needed

126

Starts

2000-03-01

Expected to finish

2005-11-01

Last updated by the study team

2021-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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
• Physician's Clinic of Iowa — Cedar Rapids, Iowa, United States
• Bluegrass Orthopaedics — Lexington, Kentucky, United States
• National Naval Medical Center — Bethesda, Maryland, United States
• Washington Orthopedic & Knee Clinic — Clinton, Maryland, United States
• Children's Hospital — Boston, Massachusetts, United States
• Pro Sports Orthopedics — Brookline, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Strong Memorial Hospital, University of Rochester — Rochester, New York, United States
• Keller Army Hospital — West Point, New York, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Beaumont Bone and Joint — Beaumont, Texas, United States
• Brooke Army Medical Center, Fort Sam — Houston, Texas, United States
• Naval Medical Center Portsmouth — Portsmouth, Virginia, United States
• Advanced Orthopedic Center — Richmond, Virginia, United States
• Northwest Orthopedic Specialists — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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