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Autologous Chondrocyte Implantation in the Patellofemoral Joint

This study has been completed.
Genzyme, a Sanofi Company
Information provided by:
Orthopaedic Research Foundation Identifier:
First received: September 13, 2005
Last updated: NA
Last verified: December 2004
History: No changes posted
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)

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.

  Contacts and Locations
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Please refer to this study by its identifier: NCT00212849

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

Publications: Identifier: NCT00212849     History of Changes
Other Study ID Numbers: JF_ACIPF091305
Study First Received: September 13, 2005
Last Updated: September 13, 2005

Keywords provided by Orthopaedic Research Foundation:
Articular Cartilage Lesions
Patellar lesions
Trochlear lesions
Patellofemoral joint
Autologous Chondrocyte Implantation processed this record on September 21, 2017