The Objectives of the Cartilage Repair Registry is to Report Long Term Efficacy and Safety of Cartilage Repair Procedures in Registry Patients
Cartilage Repair Registry
1 other identifier
observational
2,233
1 country
1
Brief Summary
The objectives of the Cartilage Repair Registry is to report the long term efficacy and safety of cartilage repair procedures in Registry patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 1995
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 1995
CompletedFirst Submitted
Initial submission to the registry
August 31, 2005
CompletedFirst Posted
Study publicly available on registry
September 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedMay 11, 2021
May 1, 2021
13.8 years
August 31, 2005
May 10, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Physician assessment of effectiveness of autologous chondrocyte implantation
Overall assessment of the patient by the physician based on knee examination and progress of rehabilitation
6 month post implantation
Physician assessment of effectiveness of autologous chondrocyte implantation
Overall assessment of the patient by the physician based on knee examination and progress of rehabilitation
12 month post implantation
Physician assessment of effectiveness of autologous chondrocyte implantation
Overall assessment of the patient by the physician based on knee examination and progress of rehabilitation
24 month post implantation
Secondary Outcomes (1)
Patient assessment of effectiveness of autologous chondrocyte implantation
6 month post implantation
Interventions
Each Carticel vial of autologous cultured chondrocytes contains approximately 12 million cells implanted into the defect and secured with a periosteal flap.
Eligibility Criteria
Registry of patients with diagnosis of chondral injury.
You may qualify if:
- All registry patients meeting the cohort definition at the pre-operative visit will be included on the overall summary tables for the patient cohort
You may not qualify if:
- All registry patients meeting the cohort definition at the pre-operative visit will be included on the overall summary tables for the patient cohort
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
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, 02142, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Genzyme, a Sanofi Company
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2005
First Posted
September 1, 2005
Study Start
March 1, 1995
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
May 11, 2021
Record last verified: 2021-05