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临床试验/NCT01329081
NCT01329081撤回不适用

Rehabilitation After Fast-track Total Knee Arthroplasty

University of Aarhus2 个研究点 分布在 1 个国家开始时间: 2011年4月5日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Oxford Knee Score

研究概览

简要总结

BACKGROUND In 2008 approximately 7,700 total knee arthroplasties (TKA) were performed in Denmark. The results after TKA is in general very good, the investigators have, however, discovered that patients following fast-track TKA still have a deficit 12 months postoperatively of 5-10% in health-related quality-of-life and 15-20% in activity and participation when compared to age- and gender matched population. A postoperative rehabilitation intervention has the potential to reduce or remove this observed deficit. The current evidence of postoperative rehabilitation after TKA is, however, scares and conflicting, and no studies have shown a lasting effect beyond 3 months postoperatively.

PURPOSE The purpose of this study is to investigate if a 6-weeks postoperative rehabilitation intervention is more effective than supervised home training, and furthermore to investigate the cost-effectiveness of the intervention in a societal perspective.

MATERIALS & METHODS The study is performed as a randomized clinical trial. In total 140 patients are included in the study. Inclusion criteria are age above 18 years, patients diagnosed as having knee arthrosis, patients receiving primary elective TKA, and patients who are able to and willing transport themselves to the rehabilitation center, which demands ability to walk 50 meter, and climb 10 stair steps. Exclusion criteria are unicompartmental or revision arthroplasty, any neurological disease, knee infection, and substantial pain or functional limitation hindering rehabilitation tested by physiotherapist prior to rehabilitation start. Primary endpoint is 6 months postoperatively and primary outcome measure is change in total score by using the knee specific questionnaire Oxford Knee Score.

研究设计

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

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age above 18 years
  • patients diagnosed as having knee arthrosis
  • patients receiving primary elective TKA and
  • patients who are able to and willing transport themselves to the rehabilitation center, which demands ability to walk 50 meter, and climb 10 stair steps

排除标准

  • unicompartmental or revision arthroplasty
  • any neurological disease
  • knee infection and
  • substantial pain or functional limitation hindering rehabilitation tested by physiotherapist prior to rehabilitation start

结局指标

主要结局

Oxford Knee Score

时间窗: Six months postoperatively

A disease specific questionnaire, which measures knee pain and function with 12 items. The questionnaire is sum scored with a range from 0 = worse pain and function to 48 = best pain and function

次要结局

  • EQ-5D(Twelve months postoperatively)

研究者

申办方类型
Other

研究点 (2)

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