ACL - Anterior Cruciate Ligament RuptureAMIVALNCT06945133
Correlation Study Between the Classification of Arthrogenic Motor Inhibition (AMI) and Clinical Assessment After ACL Rupture
A study testing Clinical testing in people with ACL - Anterior Cruciate Ligament Rupture, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 44 years
- Conditions the study is for
- ACL - Anterior Cruciate Ligament Rupture
- What is being tested?
- Clinical testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2026to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Patient with previous ipsi or contralateral knee injury/surgery
- Patient with multi-ligament injury
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Privé Jean Mermoz
Lyon, 69008
Bertrand SONNERY-COTTET, MD, PhD, +33 4 37 53 00 22, sonnerycottet@aol.com
About this study
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.
- Conditions
- ACL - Anterior Cruciate Ligament Rupture
- Being tested
- Clinical testing
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical testingOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Clinical testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From enrollment to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start1 Oct 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL - Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945133
- Sponsor's protocol ID
- 2025-A00125-44
- Other IDs
- 2025-A00125-44
- Acronym
- AMIVAL
- Status last verified
- Aug 2026
- First submitted
- 18 Apr 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Study Between the Classification of Arthrogenic Motor Inhibition (AMI) and Clinical Assessment After ACL Rupture
- ClinicalTrials.gov ID
- NCT06945133
- Acronym / sponsor ID
- AMIVAL / 2025-A00125-44
- Conditions
- ACL - Anterior Cruciate Ligament Rupture
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMI testing group | Experimental | Other: Clinical testingInterventions 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 |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patient with previous ipsi or contralateral knee injury/surgery
- Patient with multi-ligament injury
- Pregnant or breastfeeding woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical testingIntervention 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 | Other | AMI testing group |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical testing in people with ACL - Anterior Cruciate Ligament Rupture, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bertrand SONNERY-COTTET, MD,PhD (+33 4 37 53 00 22, sonnerycottet@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Surface EMG and AMI correlation (time frame: From enrollment to Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.