ChondrosisNCT00212849
Autologous Chondrocyte Implantation in the Patellofemoral Joint
An observational study of Chondrosis and Patellar Articular Cartilage Lesions, run by Orthopaedic Research Foundation at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Chondrosis, Patellar Articular Cartilage Lesions, Trochlear Articular Cartilage Lesions
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1995to Aug 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Orthopaedics Indianapolis
Indianapolis, Indiana, 46237
About this study
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)
- Keywords
- Articular Cartilage Lesions, Patellar lesions, Trochlear lesions, Patellofemoral joint, Carticel, Autologous Chondrocyte Implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJan 1995
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ChondrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Retrospective
- Enrolment
- 35 participants
Sponsor and investigators
- Lead sponsor
- Orthopaedic Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Investigators
- Jack Farr, MD, Principal investigator, Orthopaedic Research Foundation, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212849
- Sponsor's protocol ID
- JF_ACIPF091305
- Status last verified
- Dec 2004
- First submitted
- 13 Sep 2005
- Last updated
- 21 Sep 2005
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Chondrocyte Implantation in the Patellofemoral Joint
- ClinicalTrials.gov ID
- NCT00212849
- Acronym / sponsor ID
- JF_ACIPF091305
- Keywords
- Articular Cartilage Lesions, Patellar lesions, Trochlear lesions, Patellofemoral joint, Carticel, Autologous Chondrocyte Implantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants
- Lead sponsor
- Orthopaedic Research FoundationUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- Jan 1995
- Study completion
- Aug 2005
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Defined population
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2005.
- Background: PubMed 15995417Minas 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jack Farr, MD principal investigator
Orthopaedic Research Foundation, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chondrosis and Patellar Articular Cartilage Lesions, run by Orthopaedic Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00212849, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2005.