New Care Pathway Using Automated Dynamic Laximetry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Automated Dynamic Laximetry, MRI.
- Who it may be relevant to
- Registry conditions: Knee Sprain, Automated Dynamic Laximetry (ADL), Care Pathway, MRI. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
NPS-LDA - New Care Pathway Using Automated Dynamic Laximetry
Overview
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
- Procedure Automated 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. - Procedure MRI
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.
Primary outcome measures
- KOOS questionnaire [Time frame: 3 months]
- EQ-5D-5L questionnaire [Time frame: Inclusion, 1 month, 3 months, 6 months and 12 months]
Secondary outcome measures (8)
- KOOS questionnaire [Time frame: Inclusion, 1 month, 3 months and 12 months]
- Tegner activity scale [Time frame: Inclusion, 1 month, 3 months and 12 months]
- Cost per QALY gained [Time frame: 12 months]
- Time frame for therapeutic management [Time frame: inclusion and start of therapeutic management]
- Time to First Return to Sporting Activity [Time frame: 12 months]
- Time to Return to Work [Time frame: 12 months]
- Average recovery time to pre-sprain level: [Time frame: 12 months]
- budgetary impact [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 3 centers
- Chu Angers — Angers
- CH LAVAL — Laval
- Chu Nantes — Nantes
Identifiers
NCT: NCT07028476 · 49RC23_0427