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Anterior Cruciate Ligament Reconstruction: Residual Rotational Laxity for Single Versus Double Bundle Techniques (LCA IRM)

This study is currently recruiting participants.
Verified March 2013 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01377129
First received: June 17, 2011
Last updated: March 26, 2013
Last verified: March 2013
History of Changes
  Purpose

The main objective of this study is to compare, using MRI measures with a specialized splint, the persistent rotatory laxity after anterior cruciate ligament reconstruction using single bundle and double bundle surgical techniques, between the seventh and eighth months after surgery, and for different degrees of knee flexion (0 °, 20 °, 40 °, 60 °).


Condition Intervention
Anterior Cruciate Ligament Injury
 Procedure: Single bundle anterior cruciate ligament reconstruction
Procedure: Double bundle anterior cruciate ligament reconstruction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reconstruction of the Anterior Cruciate Ligament: a Comparative MRI Study Evaluating Residual Rotational Laxity for Single Versus Double Bundle Surgical Techniques

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Residual rotational laxity during MRI [ Time Frame: 7-8 months post-op ] [ Designated as safety issue: No ]
    Residual rotational laxity is defined as the difference between the operated knee and the non-operated knee for "D", where D is the distance between the posterior tibial cortex and the center of the circle which forms the lateral femoral condyle. D will be evaluated at 4 angles of flexion (0°, 20°, 40° and 60°) and evaluated as a repeated measure.


Secondary Outcome Measures:
  • Lysholm score [ Time Frame: 7-8 months ] [ Designated as safety issue: No ]
  • Lysholm score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • International Knee Documentation Committee score [ Time Frame: 7-8 months ] [ Designated as safety issue: No ]
  • International Knee Documentation Committee score [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 54
Study Start Date: October 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Single Bundle
These patients are operated using a single bundle technique.
 Procedure: Single bundle anterior cruciate ligament reconstruction
Single bundle anterior cruciate ligamentoplasty
Experimental: Double bundle
These patients are operated using a double bundle technique.
 Procedure: Double bundle anterior cruciate ligament reconstruction
Double bundle anterior cruciate ligamentoplasty

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient is available for 24 months of follow-up
  • The patient requires reconstruction of the anterior cruciate ligament due to rupture confirmed by MRI

Exclusion Criteria:

  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient is pregnant
  • The patient is breastfeeding
  • The patient require a single bundle, "KJ-type" surgical technique
  • Contra-indication for MRI scans
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01377129

Contacts
Contact: Philippe Marchand, MD +33.(0)4.66.68.72.93 philippe.marchand@chu-nimes.fr
Contact: Carey M Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
Centre Hospitalier Universitaire de Nîmes Recruiting
Nîmes Cedex 09, Gard, France, 30029
Principal Investigator: Philippe Marchand, MD            
Sub-Investigator: Nicolas Tardy, MD            
Sub-Investigator: Jean-Paul Bérégi, MD PhD            
Sub-Investigator: Dominique Blin, MD            
Sub-Investigator: Gérard Ascencio, MD PhD            
Sub-Investigator: Pascal Kouyoumdjian, MD            
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Philippe Marchand, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01377129     History of Changes
Other Study ID Numbers: LOCAL/2011/PM-03, 2011-A00465-36
Study First Received: June 17, 2011
Last Updated: March 26, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Residual Rotational Laxity

ClinicalTrials.gov processed this record on May 23, 2013