NCT06945133

Brief Summary

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.

Trial Health

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Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress40%
Dec 2025Dec 2026

First Submitted

Initial submission to the registry

April 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 25, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

1.1 years

First QC Date

April 18, 2025

Last Update Submit

November 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Muscle Surface EMG and AMI correlation

    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

Study Arms (1)

AMI testing group

EXPERIMENTAL

Interventions administered are the following : * Surface EMG to measure inhibition of the VM and the RF on the injured and non-injured sides during attempts at voluntary contractions of the knee extensor muscles. * Myotonometry to measure the stiffness of the semi-membranosus and biceps femoris (long head) on the injured and non-injured sides under resting conditions

Other: Clinical testing

Interventions

Intervention includes : * Surface EMG to measure inhibition of the VM and the rectus femoris (RF) on the injured and non-injured sides during attempts at voluntary contractions of the knee extensor muscles. * Myotonometry to measure the stiffness of the semimembranosus and biceps femoris (long head) on the injured and non-injured sides under resting conditions

AMI testing group

Eligibility Criteria

Age18 Years - 44 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Patient with previous ipsi or contralateral knee injury/surgery
  • Patient with multi-ligament injury
  • Pregnant or breastfeeding woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Privé Jean Mermoz

Lyon, 69008, France

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Clinical Laboratory Techniques

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Central Study Contacts

Bertrand SONNERY-COTTET, MD,PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

April 18, 2025

First Posted

April 25, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations