Back to resultsMedial Patellofemoral Ligament Reconstruction With or Without Lateral Retinaculum Release
Primary Purpose
Episodic Patellar Dislocation
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MPFL reconstruction and lateral retinaculum release
conventional surgery
Sponsored by
About this trial
This is an interventional treatment trial for Episodic Patellar Dislocation focused on measuring MPFL, patella, dislocation, release
Eligibility Criteria
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
Sites / Locations
- Croix-Rousse Hospital, Hospices Civils de Lyon
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
isolated MPFL reconstruction
MPFL reconstruction and Lateral retinaculum release
Arm Description
Outcomes
Primary Outcome Measures
Patellar tilt measurement
IKDC score, patellar tilt measurement on x-rays and CT-scan
Secondary Outcome Measures
rate of complications
Full Information
NCT ID
NCT01719666
First Posted
December 22, 2011
Last Updated
March 1, 2023
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT01719666
Brief Title
Medial Patellofemoral Ligament Reconstruction With or Without Lateral Retinaculum Release
Official Title
Randomized Control Trial on Lateral Retinaculum Release in MPFL Reconstruction
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 22, 2011 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators hypothesis is lateral retinaculum release has no effect on treatment of Patellar Recurrent Dislocation with Medial Patellofemoral Ligament (MPFL) reconstruction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Episodic Patellar Dislocation
Keywords
MPFL, patella, dislocation, release
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
isolated MPFL reconstruction
Arm Type
Other
Arm Title
MPFL reconstruction and Lateral retinaculum release
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
MPFL reconstruction and lateral retinaculum release
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Description
conventional surgery: MPFL reconstruction
Primary Outcome Measure Information:
Title
Patellar tilt measurement
Description
IKDC score, patellar tilt measurement on x-rays and CT-scan
Time Frame
2 years of follow up
Secondary Outcome Measure Information:
Title
rate of complications
Time Frame
2 years of follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Croix-Rousse Hospital, Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69004
Country
France
12. IPD Sharing Statement
Learn more about this trial
Medial Patellofemoral Ligament Reconstruction With or Without Lateral Retinaculum Release
We'll reach out to this number within 24 hrs