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临床试验/NCT03008967
NCT03008967已完成不适用

A Prospective Cohort Study of Patients Undergoing Total Knee and Hip Arthroplasty at a Regional Hospital in Denmark

Bornholms Regionskommune1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2016年9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
110
试验地点
1
主要终点
30 second chair stand test, to test the patients functional capacity

研究概览

简要总结

This project will be a descriptive, hypothesis-generating study. The aim is to identify risk factors for poor response to rehabilitation programs after TJR and use these to identify patients who are most susceptible to poor outcomes in order to optimise appropriate rehabilitations strategies and rationalising the distribution of health care resources.

详细描述

Fast-track surgery for total knee and hip arthroplasty has improved markedly in recent years with decreased hospitalization and postoperative complications. In 2014 there were performed over 9000 total hip arthroplasty (THA) and over 8500 total knee arthroplasty operations (TKA) in Denmark. During the same year Bornholm's regional hospital performed 85 THA's and 47 TKA's of these operations.

Even though the initial surgical procedure being technical and radiological satisfactory, there are a big proportion of patients who endure dissatisfaction and disability after total joint replacement (TJR) (between 20-40%). The strongest predictor for dissatisfaction after a TKA were found to be preoperative expectation not met postoperatively (10.7x greater risk). To date, there is no criterion standard for assessing the outcome of neither expectations nor satisfaction for patients undergoing TJR.

Patient's expectations are of a particular significance because they are linked to requests for elective and often costly treatments. Several studies have investigated the fulfillment of patient' expectations, however the focus has been primarily assessed by expectations regarding pain, but may also be influenced by several other factors. Patient's expectations are also strongly related to patient's assessments of outcome.

It is well established that there is a correlation between satisfaction of surgery and objective improvements in pain, function and general health-related quality of life, but just as patient' expectations the postoperative satisfaction may also incorporate multiple and varies factors that affect the overall outcome. One of these factors can be "ability to forget the artificial joint" in everyday life and can therefore be regarded as the ultimate possible goal for patient satisfaction.

Additionally, many patients undergoing TJR experience continued disability, which is largely caused by persistent pain postoperatively. Studies have shown that a high level of pain catastrophizing is a predictor of high levels of acute and persistent pain after various surgeries, and further investigation of pain catastrophizing as a predictor of outcome after TJR is warranted.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • patients undergoing total knee arthroplasty or total hip arthroplasty
  • must be able to participate in postoperative rehabilitation
  • must be able to talk and understand Danish or English

排除标准

  • 未提供

结局指标

主要结局

30 second chair stand test, to test the patients functional capacity

时间窗: Change of 30 second chair stand test from baseline to follow up (an average of 3 months)

次要结局

  • Health-related quality of life questionnaire(Change of health-related quality of life questionnaire from baseline to follow up (an average of 3 months))
  • Use of analgesics and other medication, qualitative assessment(Changes in the use og analgesics and other medication from baseline to follow up (an average of 3 months))
  • Patient expectations questionnaire(Preoperative (an average 3 weeks before surgery))
  • Fall history, events as numbers of falls described by the patient(Change within the fall history from baseline to follow up (an average of 3 months))
  • Patient satisfaction questionnaire(At follow up (an average of 3 months postoperative).)
  • Rehabilitation compliance(At the culmination of the rehabilitation program, an average of 10 weeks.)
  • The Forgotten Joint Score questionnaire(At follow up (an average of 3 months postoperative).)
  • Pain catastrophizing scale questionnaire(Change of pain catastrophizing scale questionnaire from baseline to follow up (an average of 3 months))

研究者

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

Troels Mark Christensen

Physiotherapist, B.Pt., M.Sc.

Bornholms Regionskommune

研究点 (1)

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