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临床试验/NCT02928835
NCT02928835已完成不适用

Effects of Dynamic Splinting on Knee Flexion Angle After Total Knee Arthroplasty: A Randomized Controlled Trial

Universidade Norte do Paraná1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年6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
已完成
发起方
入组人数
60
试验地点
1
主要终点
The knee flexion angle was assessed in supine position with a universal goniometer

研究概览

简要总结

To evaluate the effects of a knee flexion Dynasplint orthosis on knee flexion angle after a total knee arthroplasty. Sixty participants, who underwent a total knee arthroplasty, were randomly assigned in two groups: control group and Dynasplint group.

详细描述

Post-surgical rehabilitation interventions following total knee arthroplasty consist mainly of stretching exercises to improve flexibility and prevent soft tissue fibroses around the joint, thus, avoiding contractures and providing increases in the range of motion at the knee joint. Although knee manipulation and open arthrolysis may improve range of motion after total knee arthroplasty , the results have been variable and additional procedures are frequently necessary. Studies demonstrated the effectiveness of dynamic orthoses in reducing joint contractures after orthopedic surgeries in various joints that require a long rehabilitation period. Therefore, the purpose of the present study was to evaluate the effects of the knee flexion Dynasplint orthosis (KFD) on the length of rehabilitation and range of knee flexion angle after total knee arthroplasty.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •Patients enrolled will have been schedule to receive first prosthesis of the knee:
  • •Arthritis of the knee, dominated with pain Painful, deformed, and/or unstable knees secondary to degenerative or inflammatory conditions

排除标准

  • •Fractures Knee sepsis Osteomyelitis or any orthopedic infection Psoriasis Knee joint neuropathy Previous Stroke or Brain Injury Significant pathology acquired secondary to the surgery

研究组 & 干预措施

Dynasplint group

Experimental

The experimental group received standardized physical therapy intervention and used the knee flexion Dynasplint orthosis six hours daily during one month, starting at day seven after total knee arthroplasty surgery.

干预措施: Knee flexion Dynasplint orthosis (Device)

Control group

No Intervention

Control group received standardized physical therapy intervention.

结局指标

主要结局

The knee flexion angle was assessed in supine position with a universal goniometer

时间窗: Change from baseline knee flexion angle at 6 months

The outcomes were obtained by one experienced and well-trained physical therapist.

次要结局

  • Measures of knee function.(Change from baseline knee flexion angle at 6 months)
  • Measures for quality of life(Change from baseline knee flexion angle at 6 months)

研究者

发起方
Universidade Norte do Paraná
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eros de Oliveira Jr

Principal Investigator

Universidade Norte do Paraná

研究点 (1)

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