跳至主要内容
临床试验/NCT02787096
NCT02787096已完成不适用

Dynamic Knee Laxity Measurement Coupled to MRI in Cases of Suspected Partial Anterior Cruciate Ligament Tear

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2012年5月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
151
试验地点
2
主要终点
Anterior tibial translation (ATT) measurement

研究概览

简要总结

Anterior cruciate ligament (ACL) tear is frequent, but the diagnosis of partial tears is difficult. Standard MRI may be used but is of limited diagnostic value. The present study aimed to evaluate the diagnostic interest of dynamic knee laxity measurement coupled to MRI for the diagnosis of ACL tear.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • knee injury requiring MRI examination
  • accepting to participate
  • covered by a health care insurance system

排除标准

  • MRI contraindication
  • pregnancy
  • patient included in another study potentially affecting the results
  • protected patients

研究组 & 干预措施

laxIRM

Experimental

Patients will have dynamic knee laxity measurement coupled to MRI for the diagnosis of ACL tear

干预措施: LaxIRM (Device)

结局指标

主要结局

Anterior tibial translation (ATT) measurement

时间窗: 1 year after the baseline MRI-scan

Time Frame : 1 year after the baseline MRI-scan a follow-up MRI is performed if the patient did not had surgery. ATT is calculated as the difference between the distance from the tangent to the condyle to the tangent to the posterior aspect of the tibial plateau in the stress position and in resting conditions. ATT is measured for the medial and the lateral compartment respectively and the final ATT is the average of medial and lateral ATT.

次要结局

  • Degree of laxity(1 year after the baseline MRI-scan)
  • Femorotibial rotation (FTR) value(1 year after the baseline MRI-scan)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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