Anterior Cruciate Ligament RuptureCAMIKNCT03950024
Improvement of Knowledge About the Arthrogenic Muscle Inhibition in the Aftermath of Knee Trauma.
A study testing functional brain MRI in people with Anterior Cruciate Ligament Rupture, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men only
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- functional brain MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 29 Oct 2019to 11 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 30 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contribution of Functional Brain MRI to the Understanding of Arthrogenic Muscle Inhibition (AMI) in the Aftermath of Knee Trauma.
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.
Read the detailed description
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
- Anterior Cruciate Ligament Rupture
- Being tested
- functional brain MRI
- Keywords
- arthrogenic muscle inhibition, anterior cruciate ligament, functional brain MRI, Central nervous system, Knee trauma
- 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.
functional brain MRIDiagnostic test
The functional brain MRI realized will be a examination with a resting sequence and a sequence during a movement imagination task. (knee bent)
| Study group | Role | What they receive |
|---|---|---|
| with arthrogenic Muscle Inhibition | Experimental | Not described Receives: Diagnostic Test: functional brain MRI |
| without arthrogenic Muscle Inhibition | Active comparator | Not described Receives: Diagnostic Test: functional brain MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Secondary outcomes (1)
Activation map of the motor representations of knee movement
An activation map of the motor representations of knee movement are measured by MRI
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start29 Oct 2019
- Primary completion11 Jun 2024
- Study completion11 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- prospective, monocentric, interventional, comparative, controlled, non-randomized study
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Etienne CAVAIGNAC, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950024
- Sponsor's protocol ID
- RC31/19/0029
- Other IDs
- 2019-A00479-48
- Acronym
- CAMIK
- Status last verified
- Aug 2024
- First submitted
- 9 May 2019
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sonnery-Cottet B, Peran P, Grooms DR, Luaute J, Dutra Vieira T, Demaret MA, de Neve N, Carrozzo A, Cavaignac E. Cerebellar and Subcortical Connectivity Associated with Arthrogenic Muscle Inhibition After Acute ACL Rupture in Males: A Clinical and fMRI Study. Sports Med Open. 2026 Aug 26;12(1):122. doi: 10.1186/s40798-026-01096-9.
PubMed 42642554
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Functional Brain MRI to the Understanding of Arthrogenic Muscle Inhibition (AMI) in the Aftermath of Knee Trauma.
- ClinicalTrials.gov ID
- NCT03950024
- Acronym / sponsor ID
- CAMIK / RC31/19/0029
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- arthrogenic muscle inhibition, anterior cruciate ligament, functional brain MRI, Central nervous system, Knee trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 29 Oct 2019 (actual)
- Primary completion
- 11 Jun 2024 (actual)
- Study completion
- 11 Jun 2024 (actual)
- First posted
- 14 May 2019 (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.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective, monocentric, interventional, comparative, controlled, non-randomized study
| Arm | Type | Receives |
|---|---|---|
| with arthrogenic Muscle Inhibition | Experimental | Diagnostic Test: functional brain MRI |
| without arthrogenic Muscle Inhibition | Active comparator | Diagnostic Test: functional brain MRI |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
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 |
|---|---|---|
| functional brain MRIThe functional brain MRI realized will be a examination with a resting sequence and a sequence during a movement imagination task. (knee bent) | Diagnostic test | with arthrogenic Muscle Inhibition, without arthrogenic Muscle Inhibition |
Primary outcome
Matrix of correlation coefficients
Time frame: Day 0
A matrix of correlation coefficients, measured by MRI, representing the strength of the sensory-motor network connectivity at rest for each group.
1 secondary outcome
Activation map of the motor representations of knee movement
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Derived from this study: PubMed 42642554Sonnery-Cottet B, Peran P, Grooms DR, Luaute J, Dutra Vieira T, Demaret MA, de Neve N, Carrozzo A, Cavaignac E. Cerebellar and Subcortical Connectivity Associated with Arthrogenic Muscle Inhibition After Acute ACL Rupture in Males: A Clinical and fMRI Study. Sports Med Open. 2026 Aug 26;12(1):122. doi: 10.1186/s40798-026-01096-9.
- 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. This study is not recruiting at the moment.
Etienne CAVAIGNAC, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing functional brain MRI in people with Anterior Cruciate Ligament Rupture, run by University Hospital, Toulouse 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 6 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: finished, as of the sponsor's last update on 27 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Matrix of correlation coefficients (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03950024, which also lists 1 linked publication.
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 27 Aug 2024.