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

NCT ID: NCT00140634

Last Updated: 2021-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2233 participants

Study Classification

OBSERVATIONAL

Study Start Date

1995-03-31

Study Completion Date

2009-01-31

Brief Summary

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

Detailed Description

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Conditions

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Articular Cartilage Cartilage Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vericel Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Genzyme, a Sanofi Company

Locations

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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

Site Status

Countries

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United States

Other Identifiers

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Cartilage Repair Registry

Identifier Type: -

Identifier Source: org_study_id

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