NCT07028476

New Care Pathway Using Automated Dynamic Laximetry

NPS-LDA - New Care Pathway Using Automated Dynamic Laximetry

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University Hospital, Angers · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Knee Sprain
• Automated Dynamic Laximetry (ADL)
• Care Pathway
• MRI

Interventions

Type	Name	Description
PROCEDURE	Automated Dynamic Laximetry	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.
PROCEDURE	MRI	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.

Timeline

• Start date: 2026-03-10
• Primary completion: 2027-03-01
• Completion: 2028-03-01
• First posted: 2025-06-19
• Last updated: 2026-03-13

Locations

3 sites across 1 country: France