Anterior Cruciate Ligament Reconstruction: Residual Rotational Laxity for Single Versus Double Bundle Techniques

Not Applicable

Terminated

• Conditions: Anterior Cruciate Ligament Injury
• Interventions: Procedure: Single bundle anterior cruciate ligament reconstruction; Procedure: Double bundle anterior cruciate ligament reconstruction

• Registration Number: NCT01377129
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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 °).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-17
• Study First Submitted QC: 2011-06-20
• Study First Posted: 2011-06-21
• Study Start: 2011-10
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Bundle	Single bundle anterior cruciate ligament reconstruction	These patients are operated using a single bundle technique.
Double bundle	Double bundle anterior cruciate ligament reconstruction	These patients are operated using a double bundle technique.

Primary Outcome Measures

Name	Time	Method
Residual rotational laxity during MRI	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.

Secondary Outcome Measures

Name	Time	Method
Lysholm score	7-8 months
International Knee Documentation Committee score	7-8 months

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Nîmes; 🇫🇷 Nîmes Cedex 09, Gard, France