Anterior Cruciate Ligament Reconstruction: Residual Rotational Laxity for Single Versus Double Bundle Techniques (LCA IRM)
|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. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment|
|Anterior Cruciate Ligament Injury||Procedure: Single bundle anterior cruciate ligament reconstruction Procedure: Double bundle anterior cruciate ligament reconstruction|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reconstruction of the Anterior Cruciate Ligament: a Comparative MRI Study Evaluating Residual Rotational Laxity for Single Versus Double Bundle Surgical Techniques|
|Study Start Date :||October 2011|
|Primary Completion Date :||September 2014|
|Study Completion Date :||September 2014|
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
- 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.
- Lysholm score [ Time Frame: 7-8 months ]
- International Knee Documentation Committee score [ Time Frame: 7-8 months ]
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): NCT01377129
|Centre Hospitalier Universitaire de Nîmes|
|Nîmes Cedex 09, Gard, France, 30029|
|Principal Investigator:||Philippe Marchand, MD||Centre Hospitalier Universitaire de Nîmes|