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

Primary Purpose

Anterior Cruciate Ligament Injury

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Single bundle anterior cruciate ligament reconstruction
Double bundle anterior cruciate ligament reconstruction
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injury focused on measuring Residual Rotational Laxity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centre Hospitalier Universitaire de Nîmes

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Single Bundle

Double bundle

Arm Description

These patients are operated using a single bundle technique.

These patients are operated using a double bundle technique.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Lysholm score
International Knee Documentation Committee score

Full Information

First Posted
June 17, 2011
Last Updated
March 24, 2015
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT01377129
Brief Title
Anterior Cruciate Ligament Reconstruction: Residual Rotational Laxity for Single Versus Double Bundle Techniques
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
Patient enrolment proved to be more difficult than foreseen and was stopped at 46 inclusions.
Study Start Date
October 2011 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee
No

5. 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 °).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injury
Keywords
Residual Rotational Laxity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Bundle
Arm Type
Active Comparator
Arm Description
These patients are operated using a single bundle technique.
Arm Title
Double bundle
Arm Type
Experimental
Arm Description
These patients are operated using a double bundle technique.
Intervention Type
Procedure
Intervention Name(s)
Single bundle anterior cruciate ligament reconstruction
Intervention Description
Single bundle anterior cruciate ligamentoplasty
Intervention Type
Procedure
Intervention Name(s)
Double bundle anterior cruciate ligament reconstruction
Intervention Description
Double bundle anterior cruciate ligamentoplasty
Primary Outcome Measure Information:
Title
Residual rotational laxity during MRI
Description
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.
Time Frame
7-8 months post-op
Secondary Outcome Measure Information:
Title
Lysholm score
Time Frame
7-8 months
Title
International Knee Documentation Committee score
Time Frame
7-8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Marchand, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Nîmes
City
Nîmes Cedex 09
State/Province
Gard
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

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

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