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

Biological: Carticel (autologous cultured chondrocyte) implantation

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

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