NPS-LDA - New Care Pathway Using Automated Dynamic Laximetry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- EQ-5D-5L questionnaire
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Pds-IRM
干预措施: MRI (Procedure)
Pds-LDA
干预措施: Automated Dynamic Laximetry (Procedure)
结局指标
主要结局
EQ-5D-5L questionnaire
时间窗: 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).
KOOS questionnaire
时间窗: 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.
次要结局
- KOOS questionnaire(Inclusion, 1 month, 3 months and 12 months)
- Tegner activity scale(Inclusion, 1 month, 3 months and 12 months)
- Cost per QALY gained(12 months)
- Time frame for therapeutic management(inclusion and start of therapeutic management)
- Time to First Return to Sporting Activity(12 months)
- Time to Return to Work(12 months)
- Average recovery time to pre-sprain level:(12 months)
- budgetary impact(12 months)