About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Automated Dynamic Laximetry
Procedure/Surgery
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.
MRI
Procedure/Surgery
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.

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: Pds-IRMExperimental treatment 1 intervention

Group B: Pds-LDAActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame

3 months

2

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).

Time frame

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

Secondary outcomes

1

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.

Time frame

Inclusion, 1 month, 3 months and 12 months

2

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.

Time frame

Inclusion, 1 month, 3 months and 12 months

3

Cost per QALY gained

Differential cost-utility ratio (expressed as cost per QALY gained) from the perspective of the French healthcare system.

Time frame

12 months

4

Time frame for therapeutic management

Time between inclusion and the start of therapeutic management (surgery or physiotherapy).

Time frame

inclusion and start of therapeutic management

New Care Pathway Using Automated Dynamic Laximetry

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts