跳至主要内容
临床试验/NCT06259773
NCT06259773招募中不适用

The Roles of MRI, DYNEELAX and Stress X-ray in First-Line Diagnosis of Cruciate Ligament Injury

Kaohsiung Veterans General Hospital.1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
anterior/posterior tibial translation (mm)

研究概览

简要总结

Background: Cruciate ligament tears are clinically diagnosed by detection of anterior or posterior tibial translation on physical examination; however, this manual method of assessment is imprecise, subjective, and not reproducible. Recently a new instrument, a stress radiographic device and knee stability test (DYNEELAX), were produced to objectively measure these displacements.

Objective: To assess new diagnostic methods, in the measurement of anterior/posterior tibial translation in cruciate ligament-deficient knee compared to the healthy knee.

Material and method: The MRI, stress radiographic device and knee stability test was applied to cruciate ligament-tear knees that were diagnosed by physical examination as having partial or complete cruciate ligament tears. Each knee was tested under a force 120 Newtons in a posterior to anterior direction to create anterior tibial translation at 20 degrees knee flexion. Side-to-side difference of anterior/posterior tibial translation (mm) was measured from radiographs. Measurement of rotation and translation by DYNEELAX was also recorded.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients are diagnoed as ACL/PCL injury or suspect ligament sprain at Kaohsiung veteran general hospital.

排除标准

  • Unable receing MRI exam, any op history of knee or fracture history on the impaired knee.

结局指标

主要结局

anterior/posterior tibial translation (mm)

时间窗: post-op 3 months, 6 months

by Stress X-ray

patient reported outcome measure

时间窗: post-op 3 months, 6 months

Knee Outcome Survey-Activities of Daily Living Score (KOS-ADLS)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yi Ping Wei

Staff doctor

Kaohsiung Veterans General Hospital.

研究点 (1)

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