Early care pathway for knee sprains using automated dynamic laximetry
NPS-LDA - New Care Pathway Using Automated Dynamic Laximetry
This test tries using automated dynamic laximetry (ADL) right after an ER visit instead of immediate MRI to diagnose suspected ACL tears in adults with knee sprain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Angers Government |
| Locations | 3 sites (Angers and 2 other locations) |
| Trial ID | NCT07028476 on ClinicalTrials.gov |
What this trial studies
The study implements a care pathway in which ADL is performed immediately after emergency department presentation for suspected cruciate ligament injury, with MRI reserved for selected cases such as surgical planning or unclear results. Participants are adults presenting after knee trauma without radiographic fracture and who can follow up at the investigating center. The trial compares diagnostic timing, immobilization duration, and downstream use of MRI under the ADL-first pathway versus the conventional MRI-based pathway. Outcomes include diagnostic confirmation time, resource use, and potential reductions in immobilization and care costs.
Who should consider this trial
Good fit: Adults (≥18) admitted to a participating emergency department after knee trauma with clinical suspicion of partial or complete ACL lesion without fracture, able to consent and attend sports-medicine follow-up, are ideal candidates.
Not a fit: Patients who need emergency or semi-emergency surgery, who have contraindications to MRI or ADL, who cannot follow up at the investigating center, or who are pregnant or under legal/psychiatric restrictions are unlikely to benefit from this pathway.
Why it matters
Potential benefit: If successful, this approach could shorten the time to diagnosis, reduce immobilization duration, and lower costs by limiting MRI to cases that truly need it.
How similar studies have performed: Previous studies have shown ADL performs similarly to MRI as a complementary exam for diagnosing knee sprains, but applying ADL as the first-line care-pathway is a newer approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Angers and 2 other locations
- Chu Angers — Angers, France (Not_yet_recruiting)
- Ch Laval — Laval, France (Not_yet_recruiting)
- Chu Nantes — Nantes, France (Recruiting)
Study contacts
- Study coordinator: Raphaël GODET, MD
- Email: raphael.godet@chlaval.fr
- Phone: + 33 2 43 66 50 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.