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临床试验/NCT03017040
NCT03017040终止不适用

In Vivo Kinematics of Scapolunate Interosseous Ligament Injuries

Massachusetts General Hospital0 个研究点目标入组 1 人开始时间: 2015年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
1
主要终点
Patient Rated Wrist Evaluation (PRWE)

研究概览

简要总结

The investigators hypothesize that there is no relationship between in vivo kinematic abnormalities and patient-rated outcomes for scapholunate interosseous ligament injuries (SLIL)

The secondary null hypotheses are that: There are no kinematic differences between subjects with unilateral, symptomatic, full thickness scapholunate ligament tears in comparison to the contralateral wrist without scapholunate ligament injury.

The investigators aim to answer to the below questions:

  • What are baseline validated outcomes for subjects with SLIL injury?
  • What are baseline physical measures (range of motion, Jamar Dynamometry)?

详细描述

In vivo kinematics of the normal wrist has been studied previously, but few studies have characterized the wrist with a SLIL injury. There are few studies evaluating validated patient-rated outcomes for patients with SLIL injury. The goal of this study would be to evaluate to what degree kinematic abnormalities affect patient-rated outcomes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
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

  • All patients with a unilateral full thickness scapholunate ligament tear diagnosed by radiographs or advanced imaging

排除标准

  • Patients with a partial thickness scapholunate ligament tear
  • Patients with radiographic arthrosis
  • Patients with prior wrist injury
  • Pregnant women

研究组 & 干预措施

Scapholunate tear

Experimental

Subjects with a full scapholunate tear will have a CT scan and fluoroscopy images taken

干预措施: CT scan (Device)

Scapholunate tear

Experimental

Subjects with a full scapholunate tear will have a CT scan and fluoroscopy images taken

干预措施: Fluoroscopy Scan (Device)

Control Wrist

Active Comparator

Subjects will have a CT scan and fluoroscopy image taken of the contralateral wrist serve as the control.

干预措施: CT scan (Device)

Control Wrist

Active Comparator

Subjects will have a CT scan and fluoroscopy image taken of the contralateral wrist serve as the control.

干预措施: Fluoroscopy Scan (Device)

结局指标

主要结局

Patient Rated Wrist Evaluation (PRWE)

时间窗: at enrollment

The questionnaire will help the investigators determine how much difficulty the subject has had with the injured wrist in the past week.

SF-12 Patient Questionnaire

时间窗: at enrollment

The SF-12 questionnaire will help the investigators determine how well subjects are able to do usual activities

DASH Questionnaire

时间窗: at enrollment

The DASH questionnaire will help the investigators determine the level of disability subjects face from the wrist injury.

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

Neal Chung-Jen Chen

Principal Investigator

Massachusetts General Hospital

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