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临床试验/NCT04145921
NCT04145921已完成不适用

Effectiveness of Fast-track Clinical Pathway on Minimally-invasive Total Hip Arthroplasty Surgery in NTUH

National Taiwan University Hospital0 个研究点目标入组 75 人开始时间: 2014年1月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
75
主要终点
post-operative length of hospital stay

研究概览

简要总结

The objective of this study was to evaluate the effects of an enhanced recovery after surgery (ERAS) pathway incorporated with pre-operative physical therapy and education on immediate and short-term outcomes of minimally-invasive surgery of total hip arthroplasty (MIS-THA). We hypothesized that this ERAS pathway can shorten post-operative length of hospital stay and ensure same-day independent mobilization in MIS-THA. The first specific aim was to compare primary immediate outcomes, including post-operative length of hospital stay and the rate of same-day independent mobilization, between ERAS for MIS-THA patients and conventional MIS-THA patients. The second aim was to compare other immediate outcomes, including post-operative pain scores, analgesics usage, the rate of blood transfusion and post-operative nausea and vomiting (PONV), between the two groups of patients. Third, we aimed to compare short-term outcomes, including post-operative 1-year Harris hip score, Oxford hip score and EQ-5D index of quality of life, between the two groups of patients. We also compared hospital cost and profit between the two groups of patients. Moreover, we identified the factors affecting post-operative length of hospital stay in ERAS for MIS-THA patients.

详细描述

Study subjects:

We conducted a prospective comparative study to investigate 50 patients receiving an ERAS pathway incorporated with pre-operative physical therapy and education for MIS-THA and 25 patients receiving conventional MIS-THA. We included the patients with advanced osteonecrosis of femoral head or hip osteoarthritis receiving unilateral primary MIS-THA performed by the same surgeon at the same hospital. We excluded patients with renal or hepatic function impairment which precluded multimodal pain control. However, we did not preselect patients with younger age or better activity level. This study was approved by the Institutional Review Board at National Taiwan University Hospital. Written informed consent was obtained from all patients.

ERAS for MIS-THA versus conventional MIS-THA:

In this study, ERAS for MIS-THA was defined as the ERAS pathway incorporated with pre-operative short-term physical therapy and education for MIS-THA. On the other hand, conventional MIS-THA in this study was defined as the conventional pathway without pre-operative physical therapy and education for MIS-THA. Both of ERAS for MIS-THA and conventional MIS-THA comprised the same MIS-THA techniques, multimodal pain control, standardized volume management and PONV prophylaxis, deep vein thrombosis prophylaxis and post-operative rehabilitation program.

Pre-operative physical therapy and education:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • patients with advanced osteonecrosis of femoral head or hip osteoarthritis receiving unilateral primary minimally-invasive surgery of total hip arthroplasty (MIS-THA) performed by the same surgeon at the same hospital

排除标准

  • patients with renal or hepatic function impairment which precluded multimodal pain control

研究组 & 干预措施

ERAS for MIS-THA

Experimental

enhanced recovery after surgery (ERAS) pathway for minimally-invasive surgery of total hip arthroplasty (MIS-THA)

干预措施: ERAS for MIS-THA (Procedure)

conventional MIS-THA

Active Comparator

conventional pathway for minimally-invasive surgery of total hip arthroplasty (MIS-THA)

干预措施: conventional MIS-THA (Procedure)

结局指标

主要结局

post-operative length of hospital stay

时间窗: up to 2 weeks after operation

post-operative length of hospital stay

rate of same-day independent mobilization

时间窗: up to 24 hours after operation

rate of same-day independent mobilization (ambulation without assistance from another person within 24 hours after operation)

次要结局

  • rate of PONV(up to 2 weeks after operation)
  • post-operative analgesics usage(up to 2 weeks after operation)
  • post-operative 1-year EQ-5D index of quality of life(1 year after operation)
  • the rate of blood transfusion(up to 2 weeks after operation)
  • post-operative VAS pain scores(up to 24 hours after operation)
  • post-operative 1-year Harris hip score(1 year after operation)
  • post-operative 1-year Oxford hip score(1 year after operation)

研究者

申办方类型
Other
责任方
Sponsor

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