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Autologous Chondrocyte Implantation in the Patellofemoral Joint

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. Identifier: NCT00212849
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 21, 2005
Genzyme, a Sanofi Company
Information provided by:
Orthopaedic Research Foundation

Brief Summary:
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 or disease
Chondrosis Patellar Articular Cartilage Lesions Trochlear Articular Cartilage Lesions

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)

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Study Type : Observational
Enrollment : 35 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Retrospective
Official Title: Autologous Chondrocyte Implantation in the Patellofemoral Joint
Study Start Date : January 1995
Study Completion Date : August 2005

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

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.

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 identifier (NCT number): NCT00212849

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

Additional Information:
Layout table for additonal information Identifier: NCT00212849    
Other Study ID Numbers: JF_ACIPF091305
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: September 21, 2005
Last Verified: December 2004
Keywords provided by Orthopaedic Research Foundation:
Articular Cartilage Lesions
Patellar lesions
Trochlear lesions
Patellofemoral joint
Autologous Chondrocyte Implantation