Knee SprainNPS-LDANCT07028476
New Care Pathway Using Automated Dynamic Laximetry
A study testing Automated Dynamic Laximetry and MRI in people with Knee Sprain and Automated Dynamic Laximetry (ADL), run by University Hospital, Angers at 3 sites in France.
Trial summary
Today, in the event of a knee sprain with suspected cruciate ligament damage, magnetic resonance imaging (MRI) is generally prescribed to confirm or refute the diagnosis and assess its severity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Sprain, Automated Dynamic Laximetry (ADL), Care Pathway
- What is being tested?
- Automated Dynamic Laximetry and MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesFrance
- Study dates
- 10 Mar 2026to Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient admitted to an emergency department participating in the study
- Age ≥ 18 years
- Consulted following knee trauma and whose clinical examination leads to the suspicion of a partial or complete ACL lesion without bone fracture (supporting radiograph).
- Signed consent to participate in the study
- Affiliated to a social security scheme
Who cannot join
- Contraindication to MRI (pacemaker fitted before 2010) or LDA;
- Indication for emergency or semi-emergency trauma surgery (within 3 weeks: suspected unstable meniscal lesion, fracture, etc.).
- Impossible follow-up or patient's refusal of follow-up in the investigating center's sports medicine department;
- Poor understanding of the French language
- Pregnant (known or suspected pregnancy), breast-feeding or parturient woman;
- Person deprived of liberty by judicial or administrative decision;
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- Person under compulsory psychiatric care;
- Person subject to a legal protection measure
- Person unable to give consent
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Chu Angers
Angers, 49933
Antoine BRUNEAU, MD, +33 2 41 35 40 93 ext. +33, AnBruneau@chu-angers.fr
Delphine DOUILLET, MD, +33 2 41 35 36 27 ext. +33, Delphine.Douillet@chu-angers.fr
- Recruiting
CH LAVAL
Laval, 53000
Raphaël GODET, MD, +33 2 43 66 51 60 ext. +33, raphael.godet@chlaval.fr
Caroline BREMAUD, MD, +33 2 43 66 50 00 ext. +33, caroline.bremaud@chlaval.fr
- Recruiting
Chu Nantes
Nantes, 44093
Marc DAUTY, MD, +33 2 40 84 62 11 ext. +33, marc.dauty@chu-nantes.fr
About this study
Official title: NPS-LDA - New Care Pathway Using Automated Dynamic Laximetry
Today, in the event of a knee sprain with suspected cruciate ligament damage, magnetic resonance imaging (MRI) is generally prescribed to confirm or refute the diagnosis and assess its severity. Once the MRI has been performed, the patient's care is organized by the doctor of his or her choice, depending on the diagnosis.
Previous studies have shown that Automated Dynamic Laximetry (ADL) performs identically to MRI in helping to diagnose a knee sprain as a complementary examination and in assessing its severity. Performing LDA at the start of the patient's care pathway, i.e. immediately after the emergency room visit for a suspected severe sprain, could bring significant benefits by shortening the diagnostic confirmation time and consequently the immobilization period, and by reducing the cost of care compared with the conventional MRI-based care pathway. The new LDA-based care pathway would enable MRI to be reserved for very specific cases, such as the scheduling of surgery for suspected meniscus or osteochondral lesions, as currently recommended by the HAS.
- Conditions
- Knee Sprain, Automated Dynamic Laximetry (ADL), Care Pathway, MRI
- Being tested
- Automated Dynamic Laximetry, MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated Dynamic LaximetryProcedure or surgery
Patients are prescribed a Zimmer splint to immobilize the injured limb, and referred to a referring sports physician at the investigating center to perform the LDA as a confirmatory examination (complementary test). Patients arrange their appointment with the sports physician as soon as possible.
MRIProcedure or surgery
In the control arm, and in line with standard practice, patients with a suspected ACL injury are prescribed a Zimmer splint to immobilize the injured limb, an MRI as a confirmatory examination, and a consultation with the doctor of their choice. Following the MRI, patients arrange their appointments according to the usual care pathway for their pathology.
| Study group | Role | What they receive |
|---|---|---|
| Pds-IRM | Experimental | Not described Receives: Procedure: MRI |
| Pds-LDA | Active comparator | Not described Receives: Procedure: Automated Dynamic Laximetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
KOOS questionnaire
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is used to assess immediate and long-term patient outcomes following knee injury. Five outcomes are assessed by the self-administered KOOS: pain, symptoms, activities of daily living, sports and recreational function, and knee-related quality of life. KOOS meets basic standards for outcome measures and can be used to assess the evolution of the knee injury and the effectiveness of treatment. KOOS is patient-administered, has an easy-to-use format and takes around 10 minutes to complete.
Measured: 3 months
EQ-5D-5L questionnaire
The EQ5D-5L question listings are designed to analyze quality of life across 5 themes (mobility, personal autonomy, daily activities, pain/discomfort, anxiety/depression and health assessment).
Measured: Inclusion, 1 month, 3 months, 6 months and 12 months
Secondary outcomes (8)
KOOS questionnaire
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is used to assess immediate and long-term patient outcomes following knee injury. Five outcomes are assessed by the self-administered KOOS: pain, symptoms, activities of daily living, sports and recreational function, and knee-related quality of life. KOOS meets basic standards for outcome measures and can be used to assess the evolution of the knee injury and the effectiveness of treatment. KOOS is patient-administered, has an easy-to-use format and takes around 10 minutes to complete.
Measured: Inclusion, 1 month, 3 months and 12 months
Tegner activity scale
The Tegner Activity Scale is a numerical scale ranging from 0 to 10, with each value indicating the ability to perform specific activities. Higher scores represent participation in higher-level activities.
Measured: Inclusion, 1 month, 3 months and 12 months
Cost per QALY gained
Differential cost-utility ratio (expressed as cost per QALY gained) from the perspective of the French healthcare system.
Measured: 12 months
Time frame for therapeutic management
Time between inclusion and the start of therapeutic management (surgery or physiotherapy).
Measured: inclusion and start of therapeutic management
Time to First Return to Sporting Activity
Return to sport, assessed only in patients with active sporting activity.
Measured: 12 months
Time to Return to Work
Return to work under the same conditions as before the injury, assessed only in patients with employment;
Measured: 12 months
Average recovery time to pre-sprain level:
Average recovery time to pre-sprain level:
Measured: 12 months
budgetary impact
budgetary impact of changes in clinical practices regarding the two initiation points for patients, estimated from the perspective of the French national health insurance system.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start10 Mar 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee SprainStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028476
- Sponsor's protocol ID
- 49RC23_0427
- Acronym
- NPS-LDA
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NPS-LDA - New Care Pathway Using Automated Dynamic Laximetry
- ClinicalTrials.gov ID
- NCT07028476
- Acronym / sponsor ID
- NPS-LDA / 49RC23_0427
- Conditions
- Knee Sprain, Automated Dynamic Laximetry (ADL), Care Pathway, MRI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 19 Jun 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.
Today, in the event of a knee sprain with suspected cruciate ligament damage, magnetic resonance imaging (MRI) is generally prescribed to confirm or refute the diagnosis and assess its severity. Once the MRI has been performed, the patient's care is organized by the doctor of his or her choice, depending on the diagnosis.
Previous studies have shown that Automated Dynamic Laximetry (ADL) performs identically to MRI in helping to diagnose a knee sprain as a complementary examination and in assessing its severity. Performing LDA at the start of the patient's care pathway, i.e. immediately after the emergency room visit for a suspected severe sprain, could bring significant benefits by shortening the diagnostic confirmation time and consequently the immobilization period, and by reducing the cost of care compared with the conventional MRI-based care pathway. The new LDA-based care pathway would enable MRI to be reserved for very specific cases, such as the scheduling of surgery for suspected meniscus or osteochondral lesions, as currently recommended by the HAS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pds-IRM | Experimental | Procedure: MRI |
| Pds-LDA | Active comparator | Procedure: Automated Dynamic Laximetry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient admitted to an emergency department participating in the study
- Age ≥ 18 years
- Consulted following knee trauma and whose clinical examination leads to the suspicion of a partial or complete ACL lesion without bone fracture (supporting radiograph).
- Signed consent to participate in the study
- Affiliated to a social security scheme
Key exclusion criteria (9 listed)
- Contraindication to MRI (pacemaker fitted before 2010) or LDA;
- Indication for emergency or semi-emergency trauma surgery (within 3 weeks: suspected unstable meniscal lesion, fracture, etc.).
- Impossible follow-up or patient's refusal of follow-up in the investigating center's sports medicine department;
- Poor understanding of the French language
- Pregnant (known or suspected pregnancy), breast-feeding or parturient 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 |
|---|---|---|
| Automated Dynamic LaximetryPatients are prescribed a Zimmer splint to immobilize the injured limb, and referred to a referring sports physician at the investigating center to perform the LDA as a confirmatory examination (complementary test). Patients arrange their appointment with the sports physician as soon as possible. | Procedure or surgery | Pds-LDA |
| MRIIn the control arm, and in line with standard practice, patients with a suspected ACL injury are prescribed a Zimmer splint to immobilize the injured limb, an MRI as a confirmatory examination, and a consultation with the doctor of their choice. Following the MRI, patients arrange their appointments according to the usual care pathway for their pathology. | Procedure or surgery | Pds-IRM |
Primary outcome
KOOS questionnaire
Time frame: 3 months
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is used to assess immediate and long-term patient outcomes following knee injury. Five outcomes are assessed by the self-administered KOOS: pain, symptoms, activities of daily living, sports and recreational function, and knee-related quality of life. KOOS meets basic standards for outcome measures and can be used to assess the evolution of the knee injury and the effectiveness of treatment. KOOS is patient-administered, has an easy-to-use format and takes around 10 minutes to complete.
EQ-5D-5L questionnaire
Time frame: Inclusion, 1 month, 3 months, 6 months and 12 months
The EQ5D-5L question listings are designed to analyze quality of life across 5 themes (mobility, personal autonomy, daily activities, pain/discomfort, anxiety/depression and health assessment).
8 secondary outcomes
KOOS questionnaire
Time frame: Inclusion, 1 month, 3 months and 12 months
Tegner activity scale
Time frame: Inclusion, 1 month, 3 months and 12 months
Cost per QALY gained
Time frame: 12 months
Time frame for therapeutic management
Time frame: inclusion and start of therapeutic management
Time to First Return to Sporting Activity
Time frame: 12 months
Time to Return to Work
Time frame: 12 months
Average recovery time to pre-sprain level:
Time frame: 12 months
budgetary impact
Time frame: 12 months
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 18 Jun 2026.
- Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated Dynamic Laximetry and MRI in people with Knee Sprain and Automated Dynamic Laximetry (ADL), run by University Hospital, Angers at 3 sites 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Raphaël GODET, MD (+ 33 2 43 66 50 00 ext. +33, raphael.godet@chlaval.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KOOS questionnaire (time frame: 3 months). The study lists 2 primary outcomes in all. 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 18 Jun 2026.