跳至主要内容
临床试验/NCT00857701
NCT00857701终止不适用

Dynamic Splinting After Total Knee Arthroplasty: a Randomized, Controlled Trial

Dynasplint Systems, Inc.1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2009年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
25
试验地点
1
主要终点
Change in Maximal Acitive Range of Mothion in knee extension

研究概览

简要总结

The purpose of this study is to evaluate the effectiveness of a dynamic splinting system for knee flexion contracture following a total knee arthroplasty.

详细描述

The purpose of the study is to evaluate the efficacy of dynamic splinting for knee flexion contracture following a total knee arthroplasty.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Reduced flexibility in AROM of knee extension
  • •Pain that is worsened by bending over while legs are straight
  • •Impaired gait pattern
  • •Ability to understand informed consent and experiment responsibilities

排除标准

  • •Fractures
  • •Knee sepsis
  • •Osteomyelitis or any orthopedic infection
  • •Extensor mechanism dysfunction
  • •Psoriasis
  • •Knee joint neuropathy
  • •Previous Stroke or Brain Injury

研究组 & 干预措施

1

No Intervention

Patient will receive post-surgical standard of care treatment with standard Physical therapy and NSAIDs.

2

Experimental

Patients will be treated with the Standard of Care physical therapy and NSAIDs as well as a Knee Extension Dynasplint that includes tension chambers.

干预措施: Knee Extension Dynasplint (Device)

结局指标

主要结局

Change in Maximal Acitive Range of Mothion in knee extension

时间窗: 9 weeks

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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Dynamic Splinting After Total Knee Arthroplasty | 临床试验