Study of the Treatment of Articular Repair (STAR)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00158613
First received: September 8, 2005
Last updated: February 4, 2014
Last verified: February 2014

September 8, 2005
February 4, 2014
March 2000
November 2005   (final data collection date for primary outcome measure)
Mean change from baseline in the KOOS [ Time Frame: Baseline, 6 month, 12 months, 24 months, 36 months, 48 months ] [ Designated as safety issue: No ]
The time to treatment failure for the prior non-Carticel cartilage repair procedure compared to the time to treatment failure of Carticel
Complete list of historical versions of study NCT00158613 on ClinicalTrials.gov Archive Site
  • Change from Baseline in the Modified Cincinnati Score [ Time Frame: 6mo, 12mo, 18mo, 24mo, 30mo, 36mo, 42mo, 48mo ] [ Designated as safety issue: No ]
  • Change from Baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS)Which consists of five sub- categories = Pain, ADL, QOL, Symptoms, Sport [ Time Frame: 12mo, 24mo, 36mo, 48mo ] [ Designated as safety issue: No ]
  • Change from Baseline in the SF-36 Health Status Survey [ Time Frame: 12mo, 24mo, 36mo, 48mo ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Study of the Treatment of Articular Repair (STAR)
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.

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Articular Cartilage
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
Not Provided
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. Epub 2008 Oct 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
126
November 2005
November 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00158613
CARTCEL 012-99
No
Medical Monitor, Genzyme Corporation
Genzyme, a Sanofi Company
Not Provided
Study Director: Medical Monitor Genzyme, a Sanofi Company
Sanofi
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP