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

NCT ID: NCT03950024

Last Updated: 2024-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-29

Study Completion Date

2024-06-11

Brief Summary

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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.

Detailed Description

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AMI leads to quadriceps atrophy, persistent knee pain, dynamic instability, and a higher rate of osteoarthritis. A recent literature review suggests that the AMI phenomenon is multifactorial, but not widely known and poorly understood. Known mechanisms include impaired motor function at rest, impaired transmission of information from joint sensory receptors, impaired excitability of the spinal reflex and impaired cortical activity. Several studies have suggested a link between ACL rupture and central nervous system reorganization. Among the neurophysiological investigations explored are the evoked somesthesic potentials, electroencephalography, and transcranial magnetic stimulation (TMS). However, these mechanisms alone do not explain the phenomenon in its entirety, suggesting that there are other mechanisms. Furthermore, no study has used functional brain MRI to assess the existence of similar changes in AMI.

This study plans to compare two groups of patients with an ACL rupture: a group with AMI, and a group without AMI. Both groups will undergo a functional brain MRI in order to analyse any modification of the sensory-motor network connectivity that could occur.

Conditions

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Anterior Cruciate Ligament Rupture

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

prospective, monocentric, interventional, comparative, controlled, non-randomized study
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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with arthrogenic Muscle Inhibition

Group Type EXPERIMENTAL

functional brain MRI

Intervention Type 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)

without arthrogenic Muscle Inhibition

Group Type ACTIVE_COMPARATOR

functional brain MRI

Intervention Type 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)

Interventions

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functional brain MRI

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* male patient, right-handed,
* with a severe right knee sprain in the event of ACL rupture,
* occurrence of trauma within 4 weeks prior to inclusion,
* with a score of ≥ 8/10 on the Edinburgh Manual Laterality Questionnaire, -affiliated or benefiting from public health services.

Exclusion Criteria

* 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).
Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Etienne CAVAIGNAC, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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Pierre Paul Riquet Hospital

Toulouse, Occitanie, France

Site Status

Countries

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France

Other Identifiers

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2019-A00479-48

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/19/0029

Identifier Type: -

Identifier Source: org_study_id

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