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

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ClinicalTrials.gov Identifier: NCT01377129
Recruitment Status : Terminated (Patient enrolment proved to be more difficult than foreseen and was stopped at 46 inclusions.)
First Posted : June 21, 2011
Last Update Posted : March 25, 2015
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

June 17, 2011
June 21, 2011
March 25, 2015
October 2011
September 2014   (Final data collection date for primary outcome measure)
Residual rotational laxity during MRI [ Time Frame: 7-8 months post-op ]
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.
Same as current
Complete list of historical versions of study NCT01377129 on ClinicalTrials.gov Archive Site
  • Lysholm score [ Time Frame: 7-8 months ]
  • International Knee Documentation Committee score [ Time Frame: 7-8 months ]
  • Lysholm score [ Time Frame: 7-8 months ]
  • Lysholm score [ Time Frame: 24 months ]
  • International Knee Documentation Committee score [ Time Frame: 7-8 months ]
  • International Knee Documentation Committee score [ Time Frame: 24 months ]
Not Provided
Not Provided
 
Anterior Cruciate Ligament Reconstruction: Residual Rotational Laxity for Single Versus Double Bundle Techniques
Reconstruction of the Anterior Cruciate Ligament: a Comparative MRI Study Evaluating Residual Rotational Laxity for Single Versus Double Bundle Surgical Techniques
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 °).
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Anterior Cruciate Ligament Injury
  • Procedure: Single bundle anterior cruciate ligament reconstruction
    Single bundle anterior cruciate ligamentoplasty
  • Procedure: Double bundle anterior cruciate ligament reconstruction
    Double bundle anterior cruciate ligamentoplasty
  • Active Comparator: Single Bundle
    These patients are operated using a single bundle technique.
    Intervention: Procedure: Single bundle anterior cruciate ligament reconstruction
  • Experimental: Double bundle
    These patients are operated using a double bundle technique.
    Intervention: Procedure: Double bundle anterior cruciate ligament reconstruction
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
46
54
September 2014
September 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01377129
LOCAL/2011/PM-03
2011-A00465-36 ( Other Identifier: RCB number )
No
Not Provided
Not Provided
Centre Hospitalier Universitaire de Nīmes
Centre Hospitalier Universitaire de Nīmes
Not Provided
Principal Investigator: Philippe Marchand, MD Centre Hospitalier Universitaire de Nîmes
Centre Hospitalier Universitaire de Nīmes
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP