NCT07028476 New Care Pathway Using Automated Dynamic Laximetry
| NCT ID | NCT07028476 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Angers |
| Condition | Knee Sprain |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-03-10 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2026-03-10 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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; * Person under compulsory psychiatric care; * Person subject to a legal protection measure * Person unable to give consent
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07028476 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Knee Sprain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07028476 currently recruiting?
Yes, NCT07028476 is actively recruiting participants. Contact the research team at raphael.godet@chlaval.fr for enrollment information.
Where is the NCT07028476 trial being conducted?
This trial is being conducted at Angers, France, Laval, France, Nantes, France.
Who is sponsoring the NCT07028476 clinical trial?
NCT07028476 is sponsored by University Hospital, Angers. The trial plans to enroll 80 participants.