Status:
COMPLETED
Study of the Treatment of Articular Repair (STAR)
Lead Sponsor:
Vericel Corporation
Conditions:
Articular Cartilage
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- see above
Key Trial Info
Start Date :
March 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00158613
Start Date
March 1 2000
End Date
November 1 2005
Last Update
May 11 2021
Active Locations (28)
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1
Kerlan Jobe Orthopaedic Clinic
Los Angeles, California, United States, 90045
2
Naval Medical Center San Diego
San Diego, California, United States, 92134
3
Santa Monica Orthopedic Group
Santa Monica, California, United States, 90404
4
Office of Dr. Noah Weiss
Sonoma, California, United States, 95476