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New Care Pathway Using Automated Dynamic Laximetry (NPS-LDA)

U

University Hospital, Angers

Status

Not yet enrolling

Conditions

MRI
Knee Sprain
Care Pathway
Automated Dynamic Laximetry (ADL)

Treatments

Procedure: Automated Dynamic Laximetry
Procedure: MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT07028476
49RC23_0427

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

Pds-IRM
Experimental group
Treatment:
Procedure: MRI
Pds-LDA
Active Comparator group
Treatment:
Procedure: Automated Dynamic Laximetry

Trial contacts and locations

3

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Central trial contact

Raphaël GODET, MD

Data sourced from clinicaltrials.gov

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