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临床试验/NCT02401568
NCT02401568已完成不适用

Morphologic and Biomechanical Analysis of the Carpal Ligaments: a Kinematic Study on Dynamic Area Detector CT

Central Hospital, Nancy, France2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
2
主要终点
Posterior radio scaphoid angle

研究概览

简要总结

Compare various dynamic biomechanical markers (distances and angles) in the wrist during dynamic CT studies in three groups of patients: Normal subjects, with scapholunate instability and with other types of wrist instability.

详细描述

Patients referred for the evaluation of wrist pain with CT arthrography will be eligible for inclusion. Patients will benefit from dynamic CT acquisitions before and after arthrography with three maneuvers: radio-ulnar deviation, clenching fist and dart throwing motion. Patients will also benefit from a wrist MR study on a 3 tesla scanner.

The morphology of the carpal ligaments will be evaluated on static imaging (MR and CT arthrograph) and on dynamic CT arthrography.

Distance and angular measurements will be obtained from dynamic CT studies using an appropriate post processing tool (4D-Ortho).

Data obtained with dynamic wrist evaluation will be correlated to ligament morphology, classical wrist instability criteria on conventional radiographs and with surgery (if available).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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

入选标准

  • Clinical signs of wrist instability or wrist pain
  • Previous medical examination
  • Informed consent
  • Must have a social security number

排除标准

  • MR or CT contra-indications
  • No prior surgery
  • Pregnancy

结局指标

主要结局

Posterior radio scaphoid angle

时间窗: 1 Day

The angle formed between the posterior most point of the scaphoid in the sagittal plane and the ventral and dorsal rims of the distal radius will be assessed

Scapholunate angle

时间窗: 1 day

the variation in the scapholunate angle during the maneuvers performed will be assessed

Lunocapitate angle

时间窗: 1 day

the variation in the lunocapitate angle during the maneuvers performed will be assessed

scapholunate diastasis (mm)

时间窗: 1 day

The distance between the scaphoid bone and the lunate bone will be measured during all maneuvers performed

次要结局

未报告次要终点

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

研究点 (2)

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