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

14. september 2026 oppdatert av: China Medical University Hospital

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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Lin Tung-Chieh Lin Tung-Chieh, Principal Investigator
  • Telefonnummer: +886-972-856-864
  • E-post: n16548@gmail.com

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
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.
Aktiv komparator: 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.
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pain Intensity Assessed by the Numerical Rating Scale (NRS)
Tidsramme: 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.
Preoperative day, postoperative day 1, postoperative day 3, and 2 weeks after discharge
Knee Function Assessed by the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Tidsramme: 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.
Preoperative day, postoperative day 1, postoperative day 3, and 2 weeks after discharge
Physical Resilience Assessed by the Physical Resilience Instrument for Older Adults (PRIFOR)
Tidsramme: 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.
Preoperative day, postoperative day 1, postoperative day 3, and 2 weeks after discharge

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

21. september 2026

Primær fullføring (Antatt)

30. desember 2027

Studiet fullført (Antatt)

30. desember 2027

Datoer for studieregistrering

Først innsendt

14. september 2026

Først innsendt som oppfylte QC-kriteriene

14. september 2026

Først lagt ut (Faktiske)

18. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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