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

Centre Hospitalier Universitaire de Nīmes

Status: Terminated

Conditions: Anterior Cruciate Ligament Injury

Treatments: Procedure: Single bundle anterior cruciate ligament reconstruction; Procedure: Double bundle anterior cruciate ligament reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT01377129

LOCAL/2011/PM-03

2011-A00465-36 (Other Identifier)

Details and patient eligibility

About

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 °).

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Single Bundle

Active Comparator group

Description:

These patients are operated using a single bundle technique.

Treatment:

Procedure: Single bundle anterior cruciate ligament reconstruction

Double bundle

Experimental group

Description:

These patients are operated using a double bundle technique.

Treatment:

Procedure: Double bundle anterior cruciate ligament reconstruction