Improvement of Knowledge About the Arthrogenic Muscle Inhibition in the Aftermath of Knee Trauma.

NCT03950024 | Completed

• 2 other identifiers: RC31/19/00292019-A00479-48
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Arthrogenic Muscle Inhibition (AMI) is one of the classic complications occurring in the aftermath of knee trauma; AMI is grossly defined as a lack of extension due to quadriceps inhibition and hamstring contracture. However, its origins remains unknown with a strong suspicion for a central brain origin. It could be the missing link explaining this lack of extension following an anterior cruciate ligament (ACL) rupture. The primary hypothesis of this study is that a difference in activation of motor brain areas exists in patients with an ACL rupture, between those with AMI or without. The second hypothesis is that this difference could be seen on brain functional MRI.

Conditions

Anterior Cruciate Ligament Rupture

Keywords

arthrogenic muscle inhibition; anterior cruciate ligament; functional brain MRI; Central nervous system; Knee trauma

Outcome Measures

Primary Outcomes (1)

• Matrix of correlation coefficients

  A matrix of correlation coefficients, measured by MRI, representing the strength of the sensory-motor network connectivity at rest for each group.

  Day 0

Secondary Outcomes (1)

• Activation map of the motor representations of knee movement

  Day 0

Study Arms (2)

with arthrogenic Muscle Inhibition

EXPERIMENTAL

Diagnostic Test: functional brain MRI

without arthrogenic Muscle Inhibition

ACTIVE COMPARATOR

Diagnostic Test: functional brain MRI

Interventions

functional brain MRI DIAGNOSTIC_TEST

The functional brain MRI realized will be a examination with a resting sequence and a sequence during a movement imagination task. (knee bent)

with arthrogenic Muscle Inhibition; without arthrogenic Muscle Inhibition

Eligibility Criteria

• Age: 20 Years - 30 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• male patient, right-handed,
• with a severe right knee sprain in the event of ACL rupture,
• with a score of ≥ 8/10 on the Edinburgh Manual Laterality Questionnaire, -affiliated or benefiting from public health services.

You may not qualify if:

• person presenting any of these conditions : professional player / athlete, -contraindication to the MRI examination (claustrophobic patient, patient with a metallic element),
• patient already operated on with ligament damage to the knee other than ACL,
• patient with iterative ACL rupture,
• patient who has undergone contralateral ligament reconstruction,
• patient with multi-ligamentary knee injury,
• patient refusing to be informed of any abnormality detected on brain MRI, -protected patient (adults under guardianship or other legal protection, deprived of their liberty by judicial or administrative decision).

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Pierre Paul Riquet Hospital

Toulouse, Occitanie, 31300, France

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Etienne CAVAIGNAC, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: prospective, monocentric, interventional, comparative, controlled, non-randomized study

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 14, 2019
• Study Start: October 29, 2019
• Primary Completion: June 11, 2024
• Study Completion: June 11, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)