跳至主要内容
临床试验/NCT07828418
NCT07828418尚未招募不适用

A Study on the Physiological Outcomes of the Enhanced Recovery After Surgery Model in Older Adults Undergoing Total Knee Arthroplasty

China Medical University Hospital0 个研究点目标入组 60 人开始时间: 2026年9月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
Pain Intensity Assessed by the Numerical Rating Scale (NRS)

研究概览

简要总结

With the advent of an aging society, the demand for total knee arthroplasty (TKA) continues to increase. Postoperative recovery is influenced not only by the surgical procedure itself but also by pain control, joint function, and physical resilience. Enhanced Recovery After Surgery (ERAS) promotes postoperative recovery through multidisciplinary integrated care; however, related research in Taiwan remains limited, particularly studies that simultaneously examine pain, joint function, and physical resilience.

This study aims to investigate the effects of the Enhanced Recovery After Surgery (ERAS) care model on changes in postoperative pain, knee function, and physical resilience among older adults undergoing total knee arthroplasty. A quasi-experimental study with convenience sampling will be conducted. Participants will be allocated to either the ERAS group or the routine care group according to the care model received. Outcome measurements will be obtained preoperatively, on postoperative day 1, postoperative day 3, and two weeks after discharge. Pain will be assessed using the Numeric Rating Scale (NRS), knee function using the Chinese version of the Knee Injury and Osteoarthritis Outcome Score (KOOS), and physical resilience using the Physical Resilience Instrument for Older Adults (PRIFOR). Clinical recovery indicators, including vital signs, length of hospital stay, and time to first ambulation, will also be collected.

The ERAS care model is expected to improve postoperative pain, promote recovery of knee function, enhance physical resilience, shorten the length of hospital stay, and facilitate earlier ambulation. The findings of this study are expected to provide evidence for optimizing perioperative care and supporting the implementation of ERAS for older adults undergoing total knee arthroplasty.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 65 years or older. Scheduled to undergo primary unilateral total knee arthroplasty (TKA). Able to understand the study information and complete the study questionnaires. Willing to participate and provide written informed consent

排除标准

  • Undergoing revision total knee arthroplasty. Undergoing bilateral total knee arthroplasty. Cognitive impairment or communication difficulties that prevent completion of the study questionnaires

研究组 & 干预措施

ERAS Group

Experimental

Participants in this group receive a standardized Enhanced Recovery After Surgery (ERAS) care pathway, including preoperative multidimensional assessment, preoperative education, nutritional assessment, multimodal pain management, intraoperative temperature maintenance, early oral intake, early ambulation, early rehabilitation, and discharge care. The ERAS pathway is delivered by a multidisciplinary healthcare team.

干预措施: Enhanced Recovery After Surgery (ERAS) Care Pathway (Other)

Usual Care Group

Active Comparator

Participants in this group receive the hospital's usual perioperative care, including routine preoperative education, preoperative assessment, postoperative pain care, wound care, rehabilitation guidance, and discharge education according to the hospital's current care pathway.

干预措施: Usual Perioperative Care (Other)

结局指标

主要结局

Pain Intensity Assessed by the Numerical Rating Scale (NRS)

时间窗: Preoperative day, postoperative day 1, postoperative day 3, and 2 weeks after discharge

Pain intensity will be assessed using the Numerical Rating Scale (NRS), with scores ranging from 0 to 10. Higher scores indicate greater pain intensity. Changes in pain scores will be compared between the ERAS group and the usual care group across the study time points.

Knee Function Assessed by the Knee Injury and Osteoarthritis Outcome Score (KOOS)

时间窗: Preoperative day, postoperative day 1, postoperative day 3, and 2 weeks after discharge

Knee-related outcomes will be assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS), which includes five subscales: Symptoms, Pain, Activities of Daily Living, Sport and Recreation Function, and Knee-related Quality of Life. Higher scores indicate better knee-related health status.

Physical Resilience Assessed by the Physical Resilience Instrument for Older Adults (PRIFOR)

时间窗: Preoperative day, postoperative day 1, postoperative day 3, and 2 weeks after discharge

Physical resilience will be assessed using the 16-item Physical Resilience Instrument for Older Adults (PRIFOR). Changes in physical resilience scores will be compared between the ERAS group and the usual care group across the study time points.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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