Episodic Patellar DislocationNCT01719666
Medial Patellofemoral Ligament Reconstruction With or Without Lateral Retinaculum Release
A study testing MPFL reconstruction and lateral retinaculum release and conventional surgery in people with Episodic Patellar Dislocation, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The investigators hypothesis is lateral retinaculum release has no effect on treatment of Patellar Recurrent Dislocation with Medial Patellofemoral Ligament (MPFL) reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Episodic Patellar Dislocation
- What is being tested?
- MPFL reconstruction and lateral retinaculum release and conventional surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 22 Nov 2011to 20 Sep 2024
- Phase
- Interventional
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age between 18yo and 45yo
- indication for MPFL reconstruction
- unilateral or bilateral indication
Who cannot join
- indication for bony procedures
- previous surgery for PF disorders
- patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Episodic Patellar Dislocation
- Being tested
- MPFL reconstruction and lateral retinaculum release, conventional surgery
- Keywords
- MPFL, patella, dislocation, release
- Medical subject headings
- Patella Fracture, Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPFL reconstruction and lateral retinaculum releaseProcedure or surgery
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
conventional surgeryProcedure or surgery
conventional surgery: MPFL reconstruction
| Study group | Role | What they receive |
|---|---|---|
| isolated MPFL reconstruction | Other | Not described Receives: Procedure: conventional surgery |
| MPFL reconstruction and Lateral retinaculum release | Experimental | Not described Receives: Procedure: MPFL reconstruction and lateral retinaculum release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patellar tilt measurement
IKDC score, patellar tilt measurement on x-rays and CT-scan
Measured: 2 years of follow up
Secondary outcomes (1)
rate of complications
Measured: 2 years of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study start22 Nov 2011
- Primary completion20 Sep 2024
- Study completion20 Sep 2024
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 Episodic Patellar DislocationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719666
- Sponsor's protocol ID
- 2010.651
- Status last verified
- Sep 2025
- First submitted
- 22 Dec 2011
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Faure F, Erard J, Batailler C, Magnussen RA, Lustig S, Servien E. Lateral Retinacular Release During MPFL Reconstruction: A Randomized Clinical Trial. Am J Sports Med. 2025 Oct;53(12):2869-2874. doi: 10.1177/03635465251366306. Epub 2025 Sep 11.
PubMed 40934533
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial on Lateral Retinaculum Release in MPFL Reconstruction
- ClinicalTrials.gov ID
- NCT01719666
- Acronym / sponsor ID
- 2010.651
- Conditions
- Episodic Patellar Dislocation
- Keywords
- MPFL, patella, dislocation, release
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 22 Nov 2011 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 1 Nov 2012 (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 investigators hypothesis is lateral retinaculum release has no effect on treatment of Patellar Recurrent Dislocation with Medial Patellofemoral Ligament (MPFL) reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| isolated MPFL reconstruction | Other | Procedure: conventional surgery |
| MPFL reconstruction and Lateral retinaculum release | Experimental | Procedure: MPFL reconstruction and lateral retinaculum release |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age between 18yo and 45yo
- indication for MPFL reconstruction
- unilateral or bilateral indication
Key exclusion criteria (3 listed)
- indication for bony procedures
- previous surgery for PF disorders
- patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MPFL reconstruction and lateral retinaculum releaseMPFL 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 | Procedure or surgery | MPFL reconstruction and Lateral retinaculum release |
| conventional surgeryconventional surgery: MPFL reconstruction | Procedure or surgery | isolated MPFL reconstruction |
Primary outcome
Patellar tilt measurement
Time frame: 2 years of follow up
IKDC score, patellar tilt measurement on x-rays and CT-scan
1 secondary outcome
rate of complications
Time frame: 2 years of follow up
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 18 Sep 2025.
- Results publication: PubMed 40934533Faure F, Erard J, Batailler C, Magnussen RA, Lustig S, Servien E. Lateral Retinacular Release During MPFL Reconstruction: A Randomized Clinical Trial. Am J Sports Med. 2025 Oct;53(12):2869-2874. doi: 10.1177/03635465251366306. Epub 2025 Sep 11.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MPFL reconstruction and lateral retinaculum release and conventional surgery in people with Episodic Patellar Dislocation, run by Hospices Civils de Lyon at 1 site in France.
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 3 inclusion and 3 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 18 Sep 2025. 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 France. 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.
What does the primary outcome measure?
Patellar tilt measurement (time frame: 2 years of follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01719666, 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 18 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.