Anterior Cruciate Ligament TearLaxIRMNCT02787096
Dynamic Knee Laxity Measurement Coupled to MRI in Cases of Suspected Partial Anterior Cruciate Ligament Tear
A study testing LaxIRM in people with Anterior Cruciate Ligament Tear, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Anterior cruciate ligament (ACL) tear is frequent, but the diagnosis of partial tears is difficult. Standard MRI may be used but is of limited diagnostic value. The present study aimed to evaluate the diagnostic interest of dynamic knee laxity measurement coupled to MRI for the diagnosis of ACL tear. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anterior Cruciate Ligament Tear
- What is being tested?
- LaxIRM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteFrance
- Study dates
- 9 May 2012to 13 Jul 2017
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- knee injury requiring MRI examination
- accepting to participate
- covered by a health care insurance system
Who cannot join
- MRI contraindication
- pregnancy
- patient included in another study potentially affecting the results
- protected patients
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon - Hôpital Edouard Herriot Pavillon B Radiologie
Lyon, 69437
About this study
Anterior cruciate ligament (ACL) tear is frequent, but the diagnosis of partial tears is difficult. Standard MRI may be used but is of limited diagnostic value. The present study aimed to evaluate the diagnostic interest of dynamic knee laxity measurement coupled to MRI for the diagnosis of ACL tear.
- Conditions
- Anterior Cruciate Ligament Tear
- Being tested
- LaxIRM
- Keywords
- dynamic knee laxity measurement, laxi-MRI, partial anterior cruciate ligament tear
- 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.
LaxIRMDevice
Dynamic knee laxity measurement coupled to MRI for the diagnosis of ACL tear
| Study group | Role | What they receive |
|---|---|---|
| laxIRM | Experimental | Patients will have dynamic knee laxity measurement coupled to MRI for the diagnosis of ACL tear Receives: Device: LaxIRM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior tibial translation (ATT) measurement
Time Frame : 1 year after the baseline MRI-scan a follow-up MRI is performed if the patient did not had surgery.
ATT is calculated as the difference between the distance from the tangent to the condyle to the tangent to the posterior aspect of the tibial plateau in the stress position and in resting conditions. ATT is measured for the medial and the lateral compartment respectively and the final ATT is the average of medial and lateral ATT.
Measured: 1 year after the baseline MRI-scan
Secondary outcomes (2)
Degree of laxity
1 year after the baseline MRI-scan a follow-up MRI is performed if the patient did not had surgery.
Laxity of the torn ligament is defined using a visual scale with the following grading : 0 : No laxity. Grade 1: moderate laxity. Grade 2: severe laxity.
Measured: 1 year after the baseline MRI-scan
Femorotibial rotation (FTR) value
1 year after the baseline MRI-scan a follow-up MRI is performed if the patient did not had surgery.
FTR= arc tan ((ATT lateral-ATT medial)/(slice thickness*number of sagittal slices))*180/π
Measured: 1 year after the baseline MRI-scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study start9 May 2012
- Primary completion13 Jul 2017
- Study completion13 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament TearStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Baptiste PIALAT, MD, PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787096
- Sponsor's protocol ID
- 2011-685
- Acronym
- LaxIRM
- Status last verified
- Dec 2025
- First submitted
- 26 May 2016
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Pialat, Jean-Baptiste and Ltaief-Boudrigua, A. and Peyron, C. and Arion, S. and Manera, L. and Barta, A. Imagerie du genou : variantes à connaître, pièges à éviter. 44e Congrès thématique de la Société d'Imagerie Musculo-Squelettique - Le Genou. 2017-06-23/2017-06-24
Lavigne, Joris and Stacoffe, Nicolas and Heidelberg, Damien and Pialat, Jean-Baptiste. 50 cas cliniques en radiologie pédiatrique ostéoarticulaire. Journées Francophones de Radiologie Diagnostique et Interventionnelle (JFR 2018) - 2018-10-12/2018-10-15
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Knee Laxity Measurement Coupled to MRI in Cases of Suspected Partial Anterior Cruciate Ligament Tear
- ClinicalTrials.gov ID
- NCT02787096
- Acronym / sponsor ID
- LaxIRM / 2011-685
- Conditions
- Anterior Cruciate Ligament Tear
- Keywords
- dynamic knee laxity measurement, laxi-MRI, partial anterior cruciate ligament tear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 9 May 2012 (actual)
- Primary completion
- 13 Jul 2017 (actual)
- Study completion
- 13 Jul 2017 (actual)
- First posted
- 1 Jun 2016 (estimated)
- 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.
Anterior cruciate ligament (ACL) tear is frequent, but the diagnosis of partial tears is difficult. Standard MRI may be used but is of limited diagnostic value. The present study aimed to evaluate the diagnostic interest of dynamic knee laxity measurement coupled to MRI for the diagnosis of ACL tear.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| laxIRM | Experimental | Device: LaxIRMPatients will have dynamic knee laxity measurement coupled to MRI for the diagnosis of ACL tear |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- knee injury requiring MRI examination
- accepting to participate
- covered by a health care insurance system
Key exclusion criteria (4 listed)
- MRI contraindication
- pregnancy
- patient included in another study potentially affecting the results
- protected patients
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 |
|---|---|---|
| LaxIRMDynamic knee laxity measurement coupled to MRI for the diagnosis of ACL tear | Device | laxIRM |
Primary outcome
Anterior tibial translation (ATT) measurement
Time frame: 1 year after the baseline MRI-scan
Time Frame : 1 year after the baseline MRI-scan a follow-up MRI is performed if the patient did not had surgery. ATT is calculated as the difference between the distance from the tangent to the condyle to the tangent to the posterior aspect of the tibial plateau in the stress position and in resting conditions. ATT is measured for the medial and the lateral compartment respectively and the final ATT is the average of medial and lateral ATT.
2 secondary outcomes
Degree of laxity
Time frame: 1 year after the baseline MRI-scan
Femorotibial rotation (FTR) value
Time frame: 1 year after the baseline MRI-scan
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 19 Dec 2025.
- Results publicationPialat, Jean-Baptiste and Ltaief-Boudrigua, A. and Peyron, C. and Arion, S. and Manera, L. and Barta, A. Imagerie du genou : variantes à connaître, pièges à éviter. 44e Congrès thématique de la Société d'Imagerie Musculo-Squelettique - Le Genou. 2017-06-23/2017-06-24
- Results publicationLavigne, Joris and Stacoffe, Nicolas and Heidelberg, Damien and Pialat, Jean-Baptiste. 50 cas cliniques en radiologie pédiatrique ostéoarticulaire. Journées Francophones de Radiologie Diagnostique et Interventionnelle (JFR 2018) - 2018-10-12/2018-10-15
- 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.
Jean-Baptiste PIALAT, MD, PhD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LaxIRM in people with Anterior Cruciate Ligament Tear, run by Hospices Civils de Lyon 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 3 inclusion and 4 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 19 Dec 2025. 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?
Anterior tibial translation (ATT) measurement (time frame: 1 year after the baseline MRI-scan). 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 NCT02787096, which also lists 2 linked publications.
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 19 Dec 2025.