NCT02787096

Brief Summary

Anterior cruciate ligament (ACL) tear is frequent, but the diagnosis of partial tears is difficult. Standard MRI may be used but is of limited diagnostic value. The present study aimed to evaluate the diagnostic interest of dynamic knee laxity measurement coupled to MRI for the diagnosis of ACL tear.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2012

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2017

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

5.2 years

First QC Date

May 26, 2016

Last Update Submit

December 13, 2025

Conditions

Keywords

dynamic knee laxity measurementlaxi-MRIpartial anterior cruciate ligament tear

Outcome Measures

Primary Outcomes (1)

  • Anterior tibial translation (ATT) measurement

    Time Frame : 1 year after the baseline MRI-scan a follow-up MRI is performed if the patient did not had surgery. ATT is calculated as the difference between the distance from the tangent to the condyle to the tangent to the posterior aspect of the tibial plateau in the stress position and in resting conditions. ATT is measured for the medial and the lateral compartment respectively and the final ATT is the average of medial and lateral ATT.

    1 year after the baseline MRI-scan

Secondary Outcomes (2)

  • Degree of laxity

    1 year after the baseline MRI-scan

  • Femorotibial rotation (FTR) value

    1 year after the baseline MRI-scan

Study Arms (1)

laxIRM

EXPERIMENTAL

Patients will have dynamic knee laxity measurement coupled to MRI for the diagnosis of ACL tear

Device: LaxIRM

Interventions

LaxIRMDEVICE

Dynamic knee laxity measurement coupled to MRI for the diagnosis of ACL tear

laxIRM

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • knee injury requiring MRI examination
  • accepting to participate
  • covered by a health care insurance system

You may not qualify if:

  • MRI contraindication
  • pregnancy
  • patient included in another study potentially affecting the results
  • protected patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon - Hôpital Edouard Herriot Pavillon B Radiologie

Lyon, 69437, France

Location

Related Publications (2)

  • Pialat, Jean-Baptiste and Ltaief-Boudrigua, A. and Peyron, C. and Arion, S. and Manera, L. and Barta, A. Imagerie du genou : variantes à connaître, pièges à éviter. 44e Congrès thématique de la Société d'Imagerie Musculo-Squelettique - Le Genou. 2017-06-23/2017-06-24

    RESULT
  • Lavigne, Joris and Stacoffe, Nicolas and Heidelberg, Damien and Pialat, Jean-Baptiste. 50 cas cliniques en radiologie pédiatrique ostéoarticulaire. Journées Francophones de Radiologie Diagnostique et Interventionnelle (JFR 2018) - 2018-10-12/2018-10-15

    RESULT

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Jean-Baptiste PIALAT, MD, PhD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2016

First Posted

June 1, 2016

Study Start

May 9, 2012

Primary Completion

July 13, 2017

Study Completion

July 13, 2017

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations