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

• Sponsor: Centre Hospitalier Universitaire de Nīmes (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01377129
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arms: 2
• Duration (Months): 35
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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 °).

Condition or Disease	Intervention/Treatment	Phase
Anterior Cruciate Ligament Injury	Procedure: Single bundle anterior cruciate ligament reconstruction; Procedure: Double bundle anterior cruciate ligament reconstruction	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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: Oct 1, 2011
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. 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

1. Lysholm score [7-8 months]

2. International Knee Documentation Committee score [7-8 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire de Nîmes	Nîmes Cedex 09	Gard	France	30029

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nīmes

Investigators

• Principal Investigator: Philippe Marchand, MD, Centre Hospitalier Universitaire de Nîmes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nīmes
• ClinicalTrials.gov Identifier: NCT01377129
• Other Study ID Numbers: LOCAL/2011/PM-03; 2011-A00465-36
• First Posted: Jun 21, 2011
• Last Update Posted: Mar 25, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by Centre Hospitalier Universitaire de Nīmes: Residual Rotational Laxity
• Additional relevant MeSH terms: Anterior Cruciate Ligament Injuries

Study Results

No Results Posted as of Mar 25, 2015