- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Lin Tung-Chieh Lin Tung-Chieh, Principal Investigator
- Numero di telefono: +886-972-856-864
- Email: n16548@gmail.com
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Pain Intensity Assessed by the Numerical Rating Scale (NRS)
Lasso di tempo: Preoperative day, postoperative day 1, postoperative day 3, and 2 weeks after discharge
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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)
Lasso di tempo: Preoperative day, postoperative day 1, postoperative day 3, and 2 weeks after discharge
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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)
Lasso di tempo: Preoperative day, postoperative day 1, postoperative day 3, and 2 weeks after discharge
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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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Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Manifestazioni neurologiche
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Dolore
- Amministrazione dei servizi sanitari
- Procedure chirurgiche, operative
- Gestione dell'assistenza al paziente
- Cura perioperatoria
- Pianificazione dell'assistenza ai pazienti
- Assistenza sanitaria globale
- Recupero migliorato dopo l'intervento chirurgico
- Percorsi critici
Altri numeri di identificazione dello studio
- CMUH115-REC3-148
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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