NCT01719666

Brief Summary

The investigators hypothesis is lateral retinaculum release has no effect on treatment of Patellar Recurrent Dislocation with Medial Patellofemoral Ligament (MPFL) reconstruction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 22, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 22, 2011

Completed
11 months until next milestone

First Posted

Study publicly available on registry

November 1, 2012

Completed
11.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2024

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

12.8 years

First QC Date

December 22, 2011

Last Update Submit

September 12, 2025

Conditions

Keywords

MPFLpatelladislocationrelease

Outcome Measures

Primary Outcomes (1)

  • Patellar tilt measurement

    IKDC score, patellar tilt measurement on x-rays and CT-scan

    2 years of follow up

Secondary Outcomes (1)

  • rate of complications

    2 years of follow up

Study Arms (2)

isolated MPFL reconstruction

OTHER
Procedure: conventional surgery

MPFL reconstruction and Lateral retinaculum release

EXPERIMENTAL
Procedure: MPFL reconstruction and lateral retinaculum release

Interventions

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

MPFL reconstruction and Lateral retinaculum release

conventional surgery: MPFL reconstruction

isolated MPFL reconstruction

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age between 18yo and 45yo
  • indication for MPFL reconstruction
  • unilateral or bilateral indication

You may not qualify if:

  • indication for bony procedures
  • previous surgery for PF disorders
  • patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Croix-Rousse Hospital, Hospices Civils de Lyon

Lyon, 69004, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Patella FractureJoint Dislocations

Condition Hierarchy (Ancestors)

Knee FracturesFractures, BoneWounds and InjuriesJoint DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2011

First Posted

November 1, 2012

Study Start

November 22, 2011

Primary Completion

September 20, 2024

Study Completion

September 20, 2024

Last Updated

September 18, 2025

Record last verified: 2025-09

Locations