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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-09-30

Brief Summary

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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 °).

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Detailed Description

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Conditions

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Anterior Cruciate Ligament Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Bundle

These patients are operated using a single bundle technique.

Group Type ACTIVE_COMPARATOR

Single bundle anterior cruciate ligament reconstruction

Intervention Type PROCEDURE

Single bundle anterior cruciate ligamentoplasty

Double bundle

These patients are operated using a double bundle technique.

Group Type EXPERIMENTAL

Double bundle anterior cruciate ligament reconstruction

Intervention Type PROCEDURE

Double bundle anterior cruciate ligamentoplasty

Interventions

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Single bundle anterior cruciate ligament reconstruction

Single bundle anterior cruciate ligamentoplasty

Intervention Type PROCEDURE

Double bundle anterior cruciate ligament reconstruction

Double bundle anterior cruciate ligamentoplasty

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No