Clinical trial NCT00158613: Study of the Treatment of Articular Repair (STAR)
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Articular Cartilage
Lead sponsor: Vericel Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean change from baseline in the KOOS
timeFrame: Baseline, 6 month, 12 months, 24 months, 36 months, 48 months
Secondary outcomes:
measure: Change from Baseline in the Modified Cincinnati Score
timeFrame: 6mo, 12mo, 18mo, 24mo, 30mo, 36mo, 42mo, 48mo
measure: Change from Baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS)Which consists of five sub- categories = Pain, ADL, QOL, Symptoms, Sport
timeFrame: 12mo, 24mo, 36mo, 48mo
measure: Change from Baseline in the SF-36 Health Status Survey
timeFrame: 12mo, 24mo, 36mo, 48mo
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kerlan Jobe Orthopaedic Clinic
state: California
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
city: Santa Monica
country: United States
facility: Santa Monica Orthopedic Group
state: California
city: Sonoma
country: United States
facility: Office of Dr. Noah Weiss
state: California
city: Lone Tree
country: United States
facility: Denver/Vail Orthopedics
state: Colorado
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Atlanta
country: United States
facility: Atlanta Sports Medicine & Orthopaedic Center
state: Georgia
city: Chicago
country: United States
facility: Midwest Orthopedics
state: Illinois
city: Peoria
country: United States
facility: Midwest Orthopaedic Center
state: Illinois
city: Indianapolis
country: United States
facility: Orthopaedics Indianapolis
state: Indiana
city: Cedar Rapids
country: United States
facility: Physician's Clinic of Iowa
state: Iowa
city: Lexington
country: United States
facility: Bluegrass Orthopaedics
state: Kentucky
city: Bethesda
country: United States
facility: National Naval Medical Center
state: Maryland
city: Clinton
country: United States
facility: Washington Orthopedic & Knee Clinic
state: Maryland
city: Boston
country: United States
facility: Children's Hospital
state: Massachusetts
city: Brookline
country: United States
facility: Pro Sports Orthopedics
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Strong Memorial Hospital, University of Rochester
state: New York
city: West Point
country: United States
facility: Keller Army Hospital
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Beaumont
country: United States
facility: Beaumont Bone and Joint
state: Texas
city: Houston
country: United States
facility: Brooke Army Medical Center, Fort Sam
state: Texas
city: Portsmouth
country: United States
facility: Naval Medical Center Portsmouth
state: Virginia
city: Richmond
country: United States
facility: Advanced Orthopedic Center
state: Virginia
city: Spokane
country: United States
facility: Northwest Orthopedic Specialists
state: Washington
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: London
country: Canada
facility: Fowler Kennedy Sports Medicine Clinic
state: Ontario
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.