Reconstruction of the Anterior Cruciate Ligament: a Comparative MRI Study Evaluating Residual Rotational Laxity for Single Versus Double Bundle Surgical Techniques

Centre Hospitalier Universitaire de Nīmes1 site in 1 country46 target enrollmentOctober 2011

ConditionsAnterior Cruciate Ligament Injury

Overview

Phase: N/A
Intervention: Not specified
Conditions: Anterior Cruciate Ligament Injury
Sponsor: Centre Hospitalier Universitaire de Nīmes
Enrollment: 46
Locations: 1
Primary Endpoint: Residual rotational laxity during MRI
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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 °).

Registry

clinicaltrials.gov

Start Date

October 2011

End Date

September 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire de Nīmes

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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.