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

May 10, 2021 updated by: Vericel Corporation

Cartilage Repair Registry

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2233

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02142
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Registry of patients with diagnosis of chondral injury.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physician assessment of effectiveness of autologous chondrocyte implantation
Time Frame: 6 month post 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
Time Frame: 12 month post 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
Time Frame: 24 month post implantation
Overall assessment of the patient by the physician based on knee examination and progress of rehabilitation
24 month post implantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient assessment of effectiveness of autologous chondrocyte implantation
Time Frame: 6 month post 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vericel Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1995

Primary Completion (ACTUAL)

January 1, 2009

Study Completion (ACTUAL)

January 1, 2009

Study Registration Dates

First Submitted

August 31, 2005

First Submitted That Met QC Criteria

August 31, 2005

First Posted (ESTIMATE)

September 1, 2005

Study Record Updates

Last Update Posted (ACTUAL)

May 11, 2021

Last Update Submitted That Met QC Criteria

May 10, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cartilage Repair Registry

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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