Automated Dynamic Laximetry (ADL), Care Pathway, Knee Sprain, MRI
Conditions
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.
Interventions
PROCEDUREAutomated 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.
PROCEDUREMRI
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.
Sponsors
University Hospital, Angers
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| KOOS questionnaire | 3 months | 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. |
| EQ-5D-5L questionnaire | Inclusion, 1 month, 3 months, 6 months and 12 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| KOOS questionnaire | Inclusion, 1 month, 3 months and 12 months | 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. |
| Tegner activity scale | Inclusion, 1 month, 3 months and 12 months | 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. |
| Cost per QALY gained | 12 months | Differential cost-utility ratio (expressed as cost per QALY gained) from the perspective of the French healthcare system. |
| Time frame for therapeutic management | inclusion and start of therapeutic management | Time between inclusion and the start of therapeutic management (surgery or physiotherapy). |
| Time to First Return to Sporting Activity | 12 months | Return to sport, assessed only in patients with active sporting activity. |
| Time to Return to Work | 12 months | Return to work under the same conditions as before the injury, assessed only in patients with employment; |
| Average recovery time to pre-sprain level: | 12 months | Average recovery time to pre-sprain level: |
| budgetary impact | 12 months | budgetary impact of changes in clinical practices regarding the two initiation points for patients, estimated from the perspective of the French national health insurance system. |
Countries
France
Contacts
CONTACTRaphaël GODET, MD
Outcome results
None listed