Autologous Chondrocyte Implantation in the Patellofemoral Joint
September 13, 2005 updated by: Orthopaedic Research Foundation
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.
Study Overview
Status
Completed
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
Enrollment
35
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Indiana
-
Indianapolis, Indiana, United States, 46237
- Orthopaedics Indianapolis
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Defined Population
- Time Perspectives: Retrospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jack Farr, MD, Orthopaedic Research Foundation, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1995
Study Completion
August 1, 2005
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
September 21, 2005
Last Update Submitted That Met QC Criteria
September 13, 2005
Last Verified
December 1, 2004
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- JF_ACIPF091305
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.