New Care Pathway Using Automated Dynamic Laximetry

NCT07028476 | Recruiting

• 1 other identifier: 49RC23_0427
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

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

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

Outcome Measures

Primary Outcomes (3)

• 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.

  Inclusion, 1 month, 3 months, 6 months and 12 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).

  Inclusion, 1 month, 3 months, 6 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.

  Inclusion, 1 month, 3 months, 6 months and 12 months

Study Arms (2)

Pds-IRM

EXPERIMENTAL

Procedure: MRI

Pds-LDA

ACTIVE COMPARATOR

Procedure: Automated Dynamic Laximetry

Interventions

Automated Dynamic Laximetry 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.

Pds-LDA

MRI 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-IRM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (3)

Chu Angers

Angers, 49933, France

NOT YET RECRUITING

CH LAVAL

Laval, 53000, France

NOT YET RECRUITING

Chu Nantes

Nantes, 44093, France

RECRUITING

Central Study Contacts

Raphaël GODET, MD

CONTACT

+ 33 2 43 66 50 00; raphael.godet@chlaval.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 19, 2025
• Study Start: March 10, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)