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临床试验/NCT03540667
NCT03540667已完成不适用

Prospective Observational Study of Current Perioperative Care for Hip and Knee Arthroplasty in South Africa, and Associated Outcomes

University of Cape Town9 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2018年5月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
206
试验地点
9
主要终点
"Days alive and at home 30 days after surgery" (DAH30)

研究概览

简要总结

This multi-site, observational, prospective study aims to investigate current practice and associated outcomes for patients scheduled for elective unilateral total hip or knee arthroplasty in South Africa.This information will provide baseline values, against which effects of implementing a multidisciplinary enhanced care protocol for arthroplasty patients will be compared (the subsequent study).

详细描述

RESEARCH PROBLEM:

In the past 20 years, enhanced recovery pathways (ERPs) have become increasingly integrated into most surgical fields as standard care in high income countries, as is exemplified by national priority programs and the widespread acceptance of the Enhanced Recovery After Surgery (ERAS) society network. ERPs represent a fundamental shift towards a patient-centred, multidisciplinary-driven continuity of care that aim to attenuate surgical stress and expedite recovery. Studies on total joint arthroplasty (TJA) for both hips and knees have shown that implementation of an evidence-based, structured approach to patient care decreases postoperative morbidity and consequently length of stay without increasing readmission rate.

However, in low- and middle-income countries, the value of implementing ERPs is yet to be explored. This may be because: i) the perception that current hospital resources may make it difficult to develop and implement structured and sustainable protocols to enhance postoperative recovery, and ii) short and long-term data collection on the quality of the work provided is scarce, inhibiting the ability to benchmark clinical results and improve the service provided to patients. Despite these challenges, a healthcare system in a middle-income country such as South Africa may benefit from the implementation of ERPs through reduced postoperative morbidity and the associated cost reductions, as has been demonstrated in high-income countries.

STUDY RATIONAL:

Documentation of current perioperative interventions with associated postoperative outcomes is crucial before implementing a new model for perioperative care. As such, this study will give the investigators baseline values against which the perioperative results achieved from instituting a multidisciplinary enhanced care programme for South African arthroplasty patients will be analyzed.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • All patients scheduled for primary elective unilateral total hip or knee arthroplasty in the 10 week study period at the 10 participating study sites in South Africa.
  • Patients must accept to be contacted telephonically 30 days and 12 months after surgery.

排除标准

  • Patients who do not have a mobile telephone.

结局指标

主要结局

"Days alive and at home 30 days after surgery" (DAH30)

时间窗: 30 days

A patient centered measure which integrates length of hospital stay, readmission due to postoperative complications, discharge destination and early death after surgery . This outcome is an overall measure of the recovery profile as it captures much of the surgical experience, integrating efficacy, quality and safety thus reflecting value based care and actions. As such, DAH30 is transparent and can be used for benchmarking performance of quality of perioperative care.

次要结局

  • Timed Up and Go test(2-5 days after surgery)
  • EQ-5D(30 days and 1 year after surgery)
  • EQ-VAS(30 days and 1 year after surgery)
  • Satisfaction with surgery(30 days and 1 year after surgery)
  • 1-year incidence of mortality(1 year follow up)
  • Prosthetic joint infection rate(1 year follow up)
  • Joint revision(1 year follow up)

研究者

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

Margot Flint

Medical Researcher

University of Cape Town

研究点 (9)

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Study of Hip and Knee Arthroplasty in South Africa | 临床试验