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Medial Patellofemoral Ligament Reconstruction With or Without Lateral Retinaculum Release

This study is currently recruiting participants.
Verified May 2017 by Hospices Civils de Lyon
Sponsor:
ClinicalTrials.gov Identifier:
NCT01719666
First Posted: November 1, 2012
Last Update Posted: May 23, 2017
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.
Information provided by (Responsible Party):
Hospices Civils de Lyon
  Purpose
The investigators hypothesis is lateral retinaculum release has no effect on treatment of Patellar Recurrent Dislocation with Medial Patellofemoral Ligament (MPFL) reconstruction.

Condition Intervention
Episodic Patellar Dislocation Procedure: MPFL reconstruction and lateral retinaculum release Procedure: conventional surgery

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

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


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

Estimated Enrollment: 140
Actual Study Start Date: November 2011
Estimated Study Completion Date: November 2020
Estimated Primary Completion Date: November 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01719666


Contacts
Contact: Elvire SERVIEN, MD,PhD +33 4 72 26 92 51 elvire.servien@chu-lyon.fr

Locations
France
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    elvire.servien@chu-lyon.fr   
Principal Investigator: Elvire SERVIEN, MD, PhD         
Sub-Investigator: Philippe NEYRET, MD,PhD         
Sub-Investigator: Sébastien LUSTIG, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
  More Information

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01719666     History of Changes
Other Study ID Numbers: 2010.651
First Submitted: December 22, 2011
First Posted: November 1, 2012
Last Update Posted: May 23, 2017
Last Verified: May 2017

Keywords provided by Hospices Civils de Lyon:
MPFL
patella
dislocation
release

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