- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06945133
Correlation Study Between the Classification of Arthrogenic Motor Inhibition (AMI) and Clinical Assessment After ACL Rupture (AMIVAL)
The goal of this interventional study is to measure medial vastus inhibition and associate it with AMI classification in patients with ACL rupture. The main question it aims to answer is:
Is there a correlation between AMI classification and clinical assessment after ACL rupture ? Participants will undergo surface EMG and Myotonometry.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bertrand SONNERY-COTTET, MD,PhD
- Phone Number: +33 4 37 53 00 22
- Email: sonnerycottet@aol.com
Study Locations
-
-
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Lyon, France, 69008
- Hopital Prive Jean Mermoz
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Contact:
- Bertrand SONNERY-COTTET, MD, PhD
- Phone Number: +33 4 37 53 00 22
- Email: sonnerycottet@aol.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient, male or female, aged ≥ 18 years and < 45 years
- Patient with an ACL rupture confirmed by MRI
- Patient with an ACL rupture ≤ 30 days old
- French speaking patient who does not object to the use of his/her data
Exclusion Criteria:
- Patient with previous ipsi or contralateral knee injury/surgery
- Patient with multi-ligament injury
- Pregnant or breastfeeding woman
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AMI testing group
Interventions administered are the following :
|
Intervention includes :
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Surface EMG and AMI correlation
Time Frame: From enrollment to Day 30
|
Electrical signal amplitude, expressed in mV, is evaluated at the level of the VM. This electrical signal amplitude is correlated with the level of muscle activation. It is measured with a surface EMG, which measures the activation of the VM during a voluntary attempt to contract the knee extensors. The ratio: Amplitude of the electrical signal from the injured side of the VM / Amplitude of the electrical signal from the non-injured side of the VM is used to determine the inhibition of the VM. AMI is assessed using the Sonnery-Cottet classification (Sonnery-Cottet et al, 2022) |
From enrollment to Day 30
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-A00125-44 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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