Autologous Chondrocyte Implantation in the Patellofemoral Joint

This study has been completed.
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by:
Orthopaedic Research Foundation
ClinicalTrials.gov Identifier:
NCT00212849
First received: September 13, 2005
Last updated: NA
Last verified: December 2004
History: No changes posted
  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
Time Perspective: Longitudinal
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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00212849     History of Changes
Other Study ID Numbers: JF_ACIPF091305
Study First Received: September 13, 2005
Last Updated: September 13, 2005
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014