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临床试验/NCT03035435
NCT03035435已完成不适用

Fast-track Rehabilitation After Total Knee or Hip Arthroplasty: an Observational Prospective Case-control Study

Fondazione Don Carlo Gnocchi Onlus0 个研究点目标入组 58 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
58
主要终点
International Knee Society Score

研究概览

简要总结

In the last years, a lot of surgical fast track programs (SFTP) have been created and developed. This is due to the steady growing number of interventions on knee and hip; after the surgical treatment, a period of physical rehabilitation (PR) is established to be useful and effective, it usually takes 2-3 weeks. The recovery of strength, range of motion (ROM), independence, the reduction of pain and disability are the aims of PR. With the SFTP and a specific rehabilitation program named fast track rehabilitation (FTR) these times can be reduced. First of all because the length of stay (LOS) it's also caused by organizational problems of the hospitals, not only for the factors related to the patient. It's already been demonstrated that an early mobilization decreases the risk of thromboembolic complications and of pain, furthermore an early rehabilitation increase the patient autonomy and reduces the lost of residual abilities. Moreover a PR program studied for fast track patient will reduce minimum by a 50% the LOS in hospital, decreasing so the sanitary efforts that are always a problem for all the countries. The aim of this study is therefore to propose a fast track rehabilitation program based on an 8 days program for hip and knee arthroplasty being operated with an SFTP.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • adult people (>18 years), both sex, admitted for elective total knee or hip arthroplasty, with a clinical stability (Hb>9 g/l).

排除标准

  • the presence of pain measured with NRS (NRS>4)
  • rheumatoid arthritis, past surgery
  • neurological and psychiatric disorders
  • dementia with Minimental Test<24
  • pregnancy
  • participation in the other clinical studies.

结局指标

主要结局

International Knee Society Score

时间窗: Change from Baseline fast-track rehabilitation at 8th and 15th day

Merle D'Aubigne' scale

时间窗: Change from Baseline fast-track rehabilitation at 8th and 15th day

次要结局

  • Barthel Index(Change from Baseline fast-track rehabilitation at 8th and 15th day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chiara Arienti

PhD

Fondazione Don Carlo Gnocchi Onlus

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