Medial Patellofemoral Ligament Reconstruction With or Without Lateral Retinaculum Release

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01719666
First received: December 22, 2011
Last updated: May 21, 2014
Last verified: May 2013
  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
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01719666     History of Changes
Other Study ID Numbers: 2010.651
Study First Received: December 22, 2011
Last Updated: May 21, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Dislocations
Patellar Dislocation
Knee Injuries
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on October 20, 2014