The Objectives of the Cartilage Repair Registry is to Report Long Term Efficacy and Safety of Cartilage Repair Procedures in Registry Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00140634
First received: August 31, 2005
Last updated: May 22, 2015
Last verified: May 2015
  Purpose

The objectives of the Cartilage Repair Registry is to report the long term efficacy and safety of cartilage repair procedures in Registry patients.


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

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Cartilage Repair Registry

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Physician assessment of effectiveness of autologous chondrocyte implantation [ Time Frame: 6 month post implantation ] [ Designated as safety issue: No ]
    Overall assessment of the patient by the physician based on knee examination and progress of rehabilitation

  • Physician assessment of effectiveness of autologous chondrocyte implantation [ Time Frame: 12 month post implantation ] [ Designated as safety issue: No ]
    Overall assessment of the patient by the physician based on knee examination and progress of rehabilitation

  • Physician assessment of effectiveness of autologous chondrocyte implantation [ Time Frame: 24 month post implantation ] [ Designated as safety issue: No ]
    Overall assessment of the patient by the physician based on knee examination and progress of rehabilitation


Secondary Outcome Measures:
  • Patient assessment of effectiveness of autologous chondrocyte implantation [ Time Frame: 6 month post implantation ] [ Designated as safety issue: No ]
    Overall assessment of the patient by the patient based on pain, swelling, giving-way, grinding, stiffness, catching and locking and quantity of exercise


Enrollment: 2233
Study Start Date: March 1995
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Registry of patients with diagnosis of chondral injury.

Criteria

Inclusion Criteria:

  • All registry patients meeting the cohort definition at the pre-operative visit will be included on the overall summary tables for the patient cohort

Exclusion Criteria:

  • All registry patients meeting the cohort definition at the pre-operative visit will be included on the overall summary tables for the patient cohort
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00140634

Locations
United States, Massachusetts
Registry contains data from patients whom were implanted by 1123 surgeons in the U.S. and also data captured on patients treated by 154 surgeons in 15 other countries.
Cambridge, Massachusetts, United States, 02142
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00140634     History of Changes
Other Study ID Numbers: Cartilage Repair Registry
Study First Received: August 31, 2005
Last Updated: May 22, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cartilage Diseases
Connective Tissue Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on June 29, 2015