Study of the Treatment of Articular Repair (STAR) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Articular Cartilage	Biological: Carticel (autologous cultured chondrocyte) implantation	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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.

Further study details as provided by Genzyme:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	126
Study Start Date:	March 2000
Study Completion Date:	November 2005
Primary Completion Date:	November 2005 (Final data collection date for primary outcome measure)

Intervention Details:

Each Carticel vial of autologous cultured chondrocytes contains approximately 12 million cells implanted into the defect and secured with a periosteal flap

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158613

Show 28 Study Locations

Sponsors and Collaborators

Genzyme

Investigators

Study Director:

Medical Monitor

Genzyme

More Information

Publications:

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.

Responsible Party:	Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier:	NCT00158613 History of Changes
Other Study ID Numbers:	CARTCEL 012-99
Study First Received:	September 8, 2005
Last Updated:	July 28, 2009
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 19, 2013