Comparative Study of Anterior Tibial Translation Measurement by Four Different Laximeters in Anterior Cruciate Ligament Ruptures
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Comparison of anterior laxity measurement between pathologic and healthy knees.
研究概览
简要总结
Actually, there are several laximeters for measuring anterior tibial translational in case of anterior cruciate ligament rupture. The most commonly used are telos, KT-1000, GnrB and Rolimeter. Results of these instrumented tests, which expressed in differential (millimeters values), have a bad correlation between them and so are not comparable in current literature. The aim of this study was to compare results of these tests and establish a ratio (pathologic knee laxity/ healthy knee laxity) to reduce differences between each instrumented test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Obtaining a written informed consent of the patient,
- •Affiliated with a Medicare (or rightful beneficiary),
- •Disponibility of the patient,
- •Patients ≥ 18 ans,
- •Anterior cruciate ligament rupture concerned only one knee of the patient.
排除标准
- •Patient is in the exclusion period for another study,
- •Patient is under judicial protection, guardianship, or curators,
- •Eligible patients who are refused to sign consent,
- •It is impossible to give clear informations to the patient,
- •Pregnant women,
- •Nursing mother,
- •Patient which has been already operate of the other knee,
- •Patient present ligament lesions associated.
结局指标
主要结局
Comparison of anterior laxity measurement between pathologic and healthy knees.
时间窗: 18 months
Collect and compare differential values of anterior laxity between pathologic and healthy knee obtained by four different laximeters (Telos, KT-1000, GnrB and Rolimeter)
次要结局
- Correlation between the f4 laximeters results(18 months)
- Sensivity and specificity of each instrument(18 months)
- Value of the ratio : pathologic (anterior knee laxity) versus healthy knee(18 months)
研究者
Nicolas Pujol
Investigator coordinator
Versailles Hospital