New Care Pathway Using Automated Dynamic Laximetry

Официальное название

NPS-LDA - New Care Pathway Using Automated Dynamic Laximetry

Обзор

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.

Вмешательства

• Процедура 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.
• Процедура 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.

Первичные конечные точки

• KOOS questionnaire [Срок оценки: 3 months]
• EQ-5D-5L questionnaire [Срок оценки: Inclusion, 1 month, 3 months, 6 months and 12 months]

Вторичные конечные точки (8)

• KOOS questionnaire [Срок оценки: Inclusion, 1 month, 3 months and 12 months]
• Tegner activity scale [Срок оценки: Inclusion, 1 month, 3 months and 12 months]
• Cost per QALY gained [Срок оценки: 12 months]
• Time frame for therapeutic management [Срок оценки: inclusion and start of therapeutic management]
• Time to First Return to Sporting Activity [Срок оценки: 12 months]
• Time to Return to Work [Срок оценки: 12 months]
• Average recovery time to pre-sprain level: [Срок оценки: 12 months]
• budgetary impact [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 3 центра

• Chu Angers — Angers
• CH LAVAL — Laval
• Chu Nantes — Nantes

Идентификаторы

NCT: NCT07028476 · 49RC23_0427

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗