New Care Pathway Using Automated Dynamic Laximetry

NCT ID: NCT07028476

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-09-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pds-IRM

Group Type: EXPERIMENTAL

MRI

Intervention Type: PROCEDURE

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.

Pds-LDA

Group Type: ACTIVE_COMPARATOR

Automated Dynamic Laximetry

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Angers

Angers, , France

CH LAVAL

Laval, , France

Chu Nantes

Nantes, , France

Countries

France

Central Contacts

Raphaël GODET, MD

Role: CONTACT

raphael.godet@chlaval.fr

+ 33 2 43 66 50 00 ext. +33

Facility Contacts

Antoine BRUNEAU, MD

Role: primary

AnBruneau@chu-angers.fr

+33 2 41 35 40 93 ext. +33

Delphine DOUILLET, MD

Role: backup

Delphine.Douillet@chu-angers.fr

+33 2 41 35 36 27 ext. +33

Raphaël GODET, MD

Role: primary

raphael.godet@chlaval.fr

+33 2 43 66 51 60 ext. +33

Caroline BREMAUD, MD

Role: backup

caroline.bremaud@chlaval.fr

+33 2 43 66 50 00 ext. +33

Marc DAUTY, MD

Role: primary

marc.dauty@chu-nantes.fr

+33 2 40 84 62 11 ext. +33

Other Identifiers

49RC23_0427

Identifier Type: -

Identifier Source: org_study_id