Clinical Trials Directory

Trials / Completed

CompletedNCT00212849

Autologous Chondrocyte Implantation in the Patellofemoral Joint

Status
Completed
Phase
Study type
Observational
Enrollment
35 (planned)
Sponsor
Orthopaedic Research Foundation · Academic / Other
Sex
All
Age
18 Years – 50 Years
Healthy volunteers
Accepted

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.

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)

Conditions

Timeline

Start date
1995-01-01
Completion
2005-08-01
First posted
2005-09-21
Last updated
2005-09-21

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00212849. Inclusion in this directory is not an endorsement.