Medial Patellofemoral Ligament Reconstruction With or Without Lateral Retinaculum Release

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01719666
Recruitment Status : Recruiting
First Posted : November 1, 2012
Last Update Posted : May 23, 2017
Information provided by (Responsible Party):
Hospices Civils de Lyon

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

Condition or disease Intervention/treatment Phase
Episodic Patellar Dislocation Procedure: MPFL reconstruction and lateral retinaculum release Procedure: conventional surgery Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Control Trial on Lateral Retinaculum Release in MPFL Reconstruction
Actual Study Start Date : November 2011
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
isolated MPFL reconstruction Procedure: conventional surgery
conventional surgery: MPFL reconstruction

Experimental: MPFL reconstruction and Lateral retinaculum release Procedure: 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

Primary Outcome Measures :
  1. Patellar tilt measurement [ Time Frame: 2 years of follow up ]
    IKDC score, patellar tilt measurement on x-rays and CT-scan

Secondary Outcome Measures :
  1. rate of complications [ Time Frame: 2 years of follow up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01719666

Contact: Elvire SERVIEN, MD,PhD +33 4 72 26 92 51

Centre Albert Trillat, Croix-Rousse Hospital, Hospices Civils de Lyon Recruiting
Lyon, France, 69004
Contact: Elvire SERVIEN, MD, PhD    +33 4 72 26 92 51   
Principal Investigator: Elvire SERVIEN, MD, PhD         
Sub-Investigator: Philippe NEYRET, MD,PhD         
Sub-Investigator: Sébastien LUSTIG, MD         
Sponsors and Collaborators
Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon Identifier: NCT01719666     History of Changes
Other Study ID Numbers: 2010.651
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: May 2017

Keywords provided by Hospices Civils de Lyon:

Additional relevant MeSH terms:
Joint Dislocations
Patellar Dislocation
Bone Diseases
Musculoskeletal Diseases
Wounds and Injuries
Knee Injuries
Leg Injuries