Construction and Validation of a Functional Score for the Detection of Ruptures of the Anterior Cruciate Ligament in the Immediate Post-traumatic Period
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 355
- 试验地点
- 1
- 主要终点
- Reference method or "gold standard"
研究概览
简要总结
This study develops the construction and validation of a reliable functional screening score in LCA ruptures in the immediate post-traumatic period.
This score, realizable in an emergency, would be an early warning signal requiring an emergency consultation with an orthopedic surgeon. It would be a tool for screening acute LCA ruptures at a time when ligament testing maneuvers are too painful to be contributory to the diagnosis. It would avoid a premature return to dangerous activity for the knee with a rupture of the LCA.
The other impact would be economical since it would avoid the realization of unnecessary MRI.
On the other hand, it will allow patients with LCA rupture to have faster access to MRI. The hypothesis of the study is that a validated functional score would make it possible to sort the patients in the emergencies and to prescribe the MRI only in the cases of effective rupture of the LCA.
详细描述
A observational, Prospective, non-randomized, multi-centric study. The main objective of this study will be to determine the diagnostic performance (sensitivity and specificity) of a functional score for the detection of a rupture of the knee ACL in the immediate post-traumatic period.
It will follow the methodology for the evaluation of a new diagnostic test according to the STARD (Standards for Reporting of Diagnostic Accuracy) checklist.
Phases of the study
- Build score This phase will quantify the weight of each item and sub-items of the questionnaire already conceived from a statistical analysis adapted and thus to give a value to each item then a maximum value to the score.
- Validation of the score The score obtained will be validated in a different population versus MRI to determine its performance parameters. This score will be called the ACL-TS screening score (Tear Screening). An inter-evaluative reproducibility analysis of the score will be carried out in the investigative centers which have an emergency department
- Planned sample size For phase 1, a logistic regression will be performed. Empirically, there are 10 patients per variable for this questionnaire with 17 sub-items, 170 patients.
For Phase 2, the workforce was calculated on sensitivity because it is important to detect LCA ruptures. To obtain a sensitivity of 98% with a 2% CI, and taking into account a 10% rate of incomplete records, 210 patients should be included.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18 to 55 years,
- •Knee trauma occurred less than 9 days prior to hospital emergency visit or medical consultation,
- •Absence of bone fractures on the standard radiographic assessment (face and profile),
- •Patient affiliated to a social security scheme (beneficiary or beneficiary),
- •Patient informed and confirmed his / her agreement to the study.
排除标准
- •Severe knee trauma requiring immediate surgical management (fractures, dislocations)
- •Traumatic history (including sprain) on the same or other knee
- •Impossibility or refusal to do an MRI
- •Inability to understand information delivered
- •Patient's refusal
- •Patients can not be tracked for geographical reasons
结局指标
主要结局
Reference method or "gold standard"
时间窗: Between 7 days and 2 months after the accident.
MRI will be used to determine whether the LCA is broken. The direct signs of complete LCA rupture are based on its morphological study, signal and spatial orientation. * In the acute phase, haemarthrosis secondary to rupture appears as a T1-weighted hyposignal and a proton-density and T2 -weight hyper-signal. In the subacute phase, the proximal and distal stump retract and remain separated by a proton density and T2-weighted signaling area. * AND / OR: Horizontalisation of the ACL, evaluated in relation to the plane of the tibial plateaus or the Blumensaat line, indicates the complete character of the ACL rupture with a sensitivity of 89% and a specificity of 100%. * AND / OR: The "sign of the empty notch" to be sought in the frontal and axial planes is pathognomonic of the complete rupture of the LCA at its high insertion. It is the most frequent form of rupture
次要结局
- Quantification of differential laxity with GNRB(Between 3 to 8 weeks after the accident)
- Questionnaire of the score(At a day of patient inclusion)