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

Cartilage Diseases Clinical Trial

Official title:

Cartilage Repair Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00140634
• Other study ID #: Cartilage Repair Registry
• Status: Completed
• Start date: March 1995
• Est. completion date: January 2009

Study information

• Verified date: May 2021
• Source: Vericel Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2233
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Articular Cartilage
• Cartilage Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Vericel Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Patient assessment of effectiveness of autologous chondrocyte implantation	Overall assessment of the patient by the patient based on pain, swelling, giving-way, grinding, stiffness, catching and locking and quantity of exercise	6 month post implantation