Medial Patellofemoral Ligament Reconstruction With or Without Lateral Retinaculum Release

This study is currently recruiting participants.
Verified September 2013 by Hospices Civils de Lyon
Information provided by (Responsible Party):
Hospices Civils de Lyon Identifier:
First received: December 22, 2011
Last updated: September 4, 2013
Last verified: September 2013

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    IKDC score, patellar tilt measurement on x-rays and CT-scan

Secondary Outcome Measures:
  • rate of complications [ Time Frame: 2 years of follow up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 140
Study Start Date: November 2011
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (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


Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its identifier: 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
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon Identifier: NCT01719666     History of Changes
Other Study ID Numbers: 2010.651
Study First Received: December 22, 2011
Last Updated: September 4, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:

Additional relevant MeSH terms:
Patellar Dislocation
Wounds and Injuries
Knee Injuries
Leg Injuries processed this record on April 23, 2014