- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01719666
Medial Patellofemoral Ligament Reconstruction With or Without Lateral Retinaculum Release
September 12, 2025 updated by: Hospices Civils de Lyon
Randomized Control Trial on Lateral Retinaculum Release in MPFL Reconstruction
The investigators hypothesis is lateral retinaculum release has no effect on treatment of Patellar Recurrent Dislocation with Medial Patellofemoral Ligament (MPFL) reconstruction.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
140
Phase
- Not Applicable
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
-
-
-
Lyon, France, 69004
- Croix-Rousse Hospital, Hospices Civils de Lyon
-
-
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 45 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- age between 18yo and 45yo
- indication for MPFL reconstruction
- unilateral or bilateral indication
Exclusion Criteria:
- indication for bony procedures
- previous surgery for PF disorders
- patient refusal
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: isolated MPFL reconstruction
|
conventional surgery: MPFL reconstruction
|
|
Experimental: MPFL reconstruction and Lateral retinaculum release
|
MPFL is performed with a standard technique using gracilis tendon.
A tunnel is performed at the femoral part with a bioabsorbable screw fixation and 2 bundles with suture fixation at the patellar side
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patellar tilt measurement
Time Frame: 2 years of follow up
|
IKDC score, patellar tilt measurement on x-rays and CT-scan
|
2 years of follow up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
rate of complications
Time Frame: 2 years of follow up
|
2 years of follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
November 22, 2011
Primary Completion (Actual)
September 20, 2024
Study Completion (Actual)
September 20, 2024
Study Registration Dates
First Submitted
December 22, 2011
First Submitted That Met QC Criteria
October 30, 2012
First Posted (Estimated)
November 1, 2012
Study Record Updates
Last Update Posted (Estimated)
September 18, 2025
Last Update Submitted That Met QC Criteria
September 12, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010.651
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.
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