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

Anterior Cruciate Ligament Injury Clinical Trial

— LCA IRM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01377129
• Other study ID #: LOCAL/2011/PM-03
• Secondary ID: 2011-A00465-36
• Status: Terminated
• Phase: N/A
• First received: June 17, 2011
• Last updated: March 24, 2015
• Start date: October 2011
• Est. completion date: September 2014

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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 °).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injury

Intervention

Procedure:
• Single bundle anterior cruciate ligament reconstruction
Single bundle anterior cruciate ligamentoplasty
• Double bundle anterior cruciate ligament reconstruction
Double bundle anterior cruciate ligamentoplasty

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Nîmes	Nîmes Cedex 09	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual rotational laxity during MRI	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.	7-8 months post-op	No
Secondary	Lysholm score		7-8 months	No
Secondary	International Knee Documentation Committee score		7-8 months	No