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

NCT01377129 | Terminated

• 2 other identifiers: LOCAL/2011/PM-032011-A00465-36
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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 °).

Conditions

Anterior Cruciate Ligament Injury

Keywords

Residual Rotational Laxity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Lysholm score

  7-8 months

• International Knee Documentation Committee score

  7-8 months

Study Arms (2)

Single Bundle

ACTIVE COMPARATOR

These patients are operated using a single bundle technique.

Procedure: Single bundle anterior cruciate ligament reconstruction

Double bundle

EXPERIMENTAL

These patients are operated using a double bundle technique.

Procedure: Double bundle anterior cruciate ligament reconstruction

Interventions

Single bundle anterior cruciate ligament reconstruction PROCEDURE

Single bundle anterior cruciate ligamentoplasty

Single Bundle

Double bundle anterior cruciate ligament reconstruction PROCEDURE

Double bundle anterior cruciate ligamentoplasty

Double bundle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, 30029, France

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Philippe Marchand, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2011
• First Posted: June 21, 2011
• Study Start: October 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 25, 2015

Record last verified: 2015-03

Locations

FR (1)