- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07828418
A Study on the Physiological Outcomes of the Enhanced Recovery After Surgery Model in Older Adults Undergoing Total Knee Arthroplasty
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
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Lin Tung-Chieh Lin Tung-Chieh, Principal Investigator
- Telefonnummer: +886-972-856-864
- E-post: n16548@gmail.com
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Eldre voksen
Tar imot friske frivillige
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
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 |
|---|---|
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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.
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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.
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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.
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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.
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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.
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Preoperative day, postoperative day 1, postoperative day 3, and 2 weeks after discharge
|
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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.
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Preoperative day, postoperative day 1, postoperative day 3, and 2 weeks after discharge
|
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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.
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Preoperative day, postoperative day 1, postoperative day 3, and 2 weeks after discharge
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CMUH115-REC3-148
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