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OpenTrials
Completed

NCT Number: NCT00140634

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

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

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Key information

Conditions

Articular Cartilage Cartilage Diseases Connective Tissue Diseases Musculoskeletal Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carticel (autologous cultured chondrocyte) implantation

Biological

Each Carticel vial of autologous cultured chondrocytes contains approximately 12 million cells implanted into the defect and secured with a periosteal flap.

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Vericel Corporation

Industry

Registry information

Official study title

Cartilage Repair Registry

Important dates

Study start
1995
Primary completion
2009
Study completion
2009
First posted
Sep 1, 2005
Registry last updated
May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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