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Autologous Chondrocyte Implantation in the Patellofemoral Joint

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ClinicalTrials.gov Identifier: NCT00212849
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 21, 2005
Sponsor:
Collaborator:
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 Phase
Chondrosis Patellar Articular Cartilage Lesions Trochlear Articular Cartilage Lesions Phase 4

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)

Study Type : Observational
Estimated 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
Estimated Study Completion Date : August 2005




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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.


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.

Publications:
ClinicalTrials.gov Identifier: NCT00212849     History of Changes
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
Carticel
Autologous Chondrocyte Implantation