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Autologous Chondrocyte Implantation in the Patellofemoral Joint

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00212849
First Posted: September 21, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genzyme, a Sanofi Company
Information provided by:
Orthopaedic Research Foundation
  Purpose
The purpose of this study is to measure the outcomes of patients who have articular cartilage lesions in the patellofemoral joint and are treated with the Autologous Chondrocyte Implantation.

Condition Phase
Chondrosis Patellar Articular Cartilage Lesions Trochlear Articular Cartilage Lesions Phase 4

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Retrospective
Official Title: Autologous Chondrocyte Implantation in the Patellofemoral Joint

Further study details as provided by Orthopaedic Research Foundation:

Estimated Enrollment: 35
Study Start Date: January 1995
Estimated Study Completion Date: August 2005
Detailed Description:
Cartilage restoration, in general, is a relatively new option for the treatment of articular cartilage lesions primarily of the knee. In the initial autologous cultured chondrocyte transplantation (ACT or, by others implantation, thus ACI) reported by Peterson et. al., the results of femoral lesions were favorable, while 5 of 7 patellofemoral treatments were poor. In the United States, the expedited FDA approval based on these results excluded the patella. As a result, in the United States, it has been difficult to further evaluate use of ACI at the patellofemoral joint in light of the exclusion of “off label” uses by many governmental and private insurance programs. Nevertheless, a growing body of knowledge is accumulating outside the United States that the use of ACI at the patella is a viable option and soon similar findings will be published in the US by Minas et. al. (accepted for publication)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Carticel Implantation of the patella and/or trochlear lesion. Patients who have reached their two-year follow-up date. All patients included in sequential order.

Exclusion Criteria:

  • Patients that have had a microfracture in the knee joint at the same time as Carticel Implantation.

Patients that have implantable lesions other than the patella and trochlea.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00212849


Locations
United States, Indiana
Orthopaedics Indianapolis
Indianapolis, Indiana, United States, 46237
Sponsors and Collaborators
Orthopaedic Research Foundation
Genzyme, a Sanofi Company
Investigators
Principal Investigator: Jack Farr, MD Orthopaedic Research Foundation, Inc.
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00212849     History of Changes
Other Study ID Numbers: JF_ACIPF091305
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: December 9, 2005
Last Verified: December 2004

Keywords provided by Orthopaedic Research Foundation:
Articular Cartilage Lesions
Patellar lesions
Trochlear lesions
Patellofemoral joint
Carticel
Autologous Chondrocyte Implantation