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临床试验/NCT00175201
NCT00175201已完成不适用

From Efficacy to Effectiveness of a Proactive Perioperative Care and Rehabilitation in Patients Undergoing Primary Total Hip or Knee Replacement

University of Aarhus2 个研究点 分布在 1 个国家目标入组 247 人开始时间: 2005年5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
247
试验地点
2
主要终点
Pain

研究概览

简要总结

In this randomised study a proactive care and rehabilitation intervention is compared to the current care and rehabilitation in patients undergoing primary hip and knee replacement surgery.

A cost efficacy analysis in a societal perspective is made from effect data in the randomised controlled study together with cost data gathered during the perioperative and postoperative period.

If the proactive care and rehabilitation intervention is cost effective the intervention is going to be implemented in Ringkøbing County. This implementation proces is measured within a monitoring project of all patients receiving hip or knee replacement surgery in Ringkøbing County in the period 2003 to 2007.

详细描述

BACKBROUND Hip and knee replacement are commonly performed surgical procedures, with more than 800,000 hip operations carried out worldwide each year and with almost 550 hip and knee replacements each year in Ringkoebing County. The main indicators for total hip or knee replacement are intractable pain and/or limitation of function that cannot be managed by conservative treatment alone. Leading causes of such pain include osteoarthritis, rheumatoid arthritis, trauma, congenital abnormalities, dysplasia and osteochondritic disease. In the absence of treatments that provide a cure for conditions such as osteoarthritis, management is directed primarily towards relieving pain and re-ducing functional limitation. Joint replacement is one surgical option when medical treatment has failed to provide adequate symptom relief. Hip or knee replacement is a major surgical procedure that requires inpatient physiotherapy and out-patient rehabilitation following a stay in hospital.

Regarding the effect of optimizing the perioperative period, no systemically critical reviews of randomized controlled trials (RCT) could be identified. Only one RCT of the effect of a clinical pathway in hip and knee arthroplasty could be identified, the study by Dowsey et al from 1999, which concludes that the intervention gives a better effect and reduces the average length of stay with 1.5 day. No cost data were reported in this study. A systematic review of clinical pathways including the study by Dowsey et al and ten non-RCT studies concludes that clinical pathways for total knee and total hip arthroplasty reduces costs and length of stay. A significant and great reduction in length of stay is reported from two resent Danish non-RCT, the study by Rasmussen et al, in which an accelerated and proactive care was given and the study by Husted et al, in which no extra resources were allocated but the care was given in a special unit focusing on a length of stay of maximal 8 days. However nothing is known about the cost or effects of this accelerated and proactive care out-side the hospital.

In summary the overall evidence level on accelerated perioperative care and rehabilitation for patients undergoing total hip or knee replacement is scarce.

OBJECTIVES To investigate the cost efficacy of a focused and specialized care unit in patients undergoing total hip or knee replacement

To investigate the cost effectiveness of a focused and specialized care unit in patients under-going total hip or knee replacement

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

性别
All
接受健康志愿者

入选标准

  • Primary osteoarthritis of the hip and knee -

排除标准

  • Non-cooperative Replacement secondary to fracture Revision surgery

结局指标

主要结局

Pain

Disabillity

Costs

Health relatede quality of life

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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