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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
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.
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.
Chu Angers
Angers, France
CH LAVAL
Laval, France
Chu Nantes
Nantes, France
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, 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).
Time frame: 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.
Time frame: Inclusion, 1 month, 3 months, 6 months and 12 months
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