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CompletedNCT00212849Updated Sep 21, 2005

Autologous Chondrocyte Implantation in the Patellofemoral Joint

An observational study in Chondrosis, Patellar Articular Cartilage Lesions and Trochlear Articular Cartilage Lesions, sponsored by Orthopaedic Research Foundation. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2005-09-21.

Sponsored by Orthopaedic Research Foundation · Observational

Study type
Observational
Model
Defined population
Time perspective
Retrospective
Enrollment
35
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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)

02

Conditions studied

  • Chondrosis
  • Patellar Articular Cartilage Lesions
  • Trochlear Articular Cartilage Lesions

Keywords

  • Articular Cartilage Lesions
  • Patellar lesions
  • Trochlear lesions
  • Patellofemoral joint
  • Carticel
  • Autologous Chondrocyte Implantation
03

In context

Lead sponsor

Orthopaedic Research Foundation is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
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

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.

05

Study design

Observational model
Defined population
Time perspective
Retrospective
Enrollment
35 participants
06

Study locations

1 site
  • Orthopaedics Indianapolis
    Indianapolis, Indiana 46237, United States
07

References and documents

Publications

  • Minas T, Bryant T. The role of autologous chondrocyte implantation in the patellofemoral joint. Clin Orthop Relat Res. 2005 Jul;(436):30-9. doi: 10.1097/01.blo.0000171916.40245.5d. PubMed 15995417 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00212849
Lead sponsor
Orthopaedic Research Foundation
Collaborators
Genzyme, a Sanofi Company
First posted
Sep 21, 2005
Start date
Jan 1995
Completion
Aug 2005
Last update
Sep 21, 2005

Study contacts

Jack Farr, MD
principal investigator · Orthopaedic Research Foundation, Inc.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2004. You cannot join it, but the record below documents what was studied.

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