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Not yet recruitingNCT07828418Updated Sep 21, 2026

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

An interventional study of Enhanced Recovery After Surgery (ERAS) Care Pathway and Usual Perioperative Care in Total Knee Arthroplasty (Replacement), sponsored by China Medical University Hospital. Not yet recruiting. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by China Medical University Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
65 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Total Knee Arthroplasty (Replacement)

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Keywords

  • Enhanced Recovery After Surgery
  • Total Knee Arthroplasty
  • Older Adults
  • Pain
  • Knee Function
  • Physical Resilience
03

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Aged 65 years or older
  • Scheduled to undergo primary unilateral elective total knee arthroplasty (TKA)
  • Conscious and able to communicate in Mandarin Chinese or Taiwanese
  • Willing to complete the study questionnaires and provide written informed consent

Exclusion criteria

Exclusion Criteria:

  • Cognitive impairment (e.g., moderate or severe dementia) or psychiatric illness that prevents adequate understanding, communication, or study participation
  • Postoperative transfer to an intensive care unit, repeat surgery, or death
  • Withdrawal of willingness to continue study participation during the study period
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    ERAS Group

    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.

    Other: Enhanced Recovery After Surgery (ERAS) Care Pathway

  • Active comparator
    Usual Care Group

    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.

    Other: Usual Perioperative Care

Interventions

  • OtherEnhanced Recovery After Surgery (ERAS) Care Pathway

    A standardized multidisciplinary perioperative 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.

  • OtherUsual Perioperative Care

    Usual perioperative care according to the hospital's current care pathway, including routine preoperative education, preoperative assessment, postoperative pain care, wound care, rehabilitation guidance, and discharge education.

05

What researchers measure

Primary outcomes

  1. Pain Intensity Assessed by the Numerical Rating Scale (NRS)

    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.

    Time frame: Preoperative day, postoperative day 1, postoperative day 3, and 2 weeks after discharge

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

    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.

    Time frame: Preoperative day, postoperative day 1, postoperative day 3, and 2 weeks after discharge

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

    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.

    Time frame: Preoperative day, postoperative day 1, postoperative day 3, and 2 weeks after discharge

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared because data sharing is not included in the approved study protocol or informed consent. Study data will be maintained confidentially in accordance with institutional and ethical requirements.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07828418
Lead sponsor
China Medical University Hospital
Responsible party
Sponsor
First posted
Sep 18, 2026
Start date
Sep 21, 2026 (estimated)
Primary completion
Dec 30, 2027 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Sep 21, 2026

Study contacts

Lin Tung-Chieh Lin Tung-Chieh, Principal Investigator
Contact
n16548@gmail.com
+886-972-856-864

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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