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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01377129

Acronym

LCA IRM

Enrollment

Registered

2011-06-21

Start date

2011-10-31

Completion date

2014-09-30

Last updated

2015-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Injury

Keywords

Residual Rotational Laxity

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 °).

Interventions

PROCEDURESingle bundle anterior cruciate ligament reconstruction

Single bundle anterior cruciate ligamentoplasty

PROCEDUREDouble bundle anterior cruciate ligament reconstruction

Double bundle anterior cruciate ligamentoplasty

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Lysholm score	7-8 months
International Knee Documentation Committee score	7-8 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026