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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pds-IRM | Experimental |
| |
| Pds-LDA | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raphaƫl GODET, MD | Contact | + 33 2 43 66 50 00 | +33 | raphael.godet@chlaval.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Angers | Recruiting | Angers | 49933 | France |
Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).
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| 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. |
|
| Inclusion, 1 month, 3 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 and 12 months |
| Cost per QALY gained | Differential cost-utility ratio (expressed as cost per QALY gained) from the perspective of the French healthcare system. | 12 months |
| Time frame for therapeutic management | Time between inclusion and the start of therapeutic management (surgery or physiotherapy). | inclusion and start of therapeutic management |
| Time to First Return to Sporting Activity | Return to sport, assessed only in patients with active sporting activity. | 12 months |
| Time to Return to Work | Return to work under the same conditions as before the injury, assessed only in patients with employment; | 12 months |
| Average recovery time to pre-sprain level: | Average recovery time to pre-sprain level: | 12 months |
| budgetary impact | 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. | 12 months |
| CH LAVAL | Recruiting | Laval | 53000 | France |
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| Chu Nantes | Recruiting | Nantes | 44093 | France |
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