- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Lin Tung-Chieh Lin Tung-Chieh, Principal Investigator
- Numéro de téléphone: +886-972-856-864
- E-mail: n16548@gmail.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pain Intensity Assessed by the Numerical Rating Scale (NRS)
Délai: 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)
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Manifestations neurologiques
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- La douleur
- Administration des services de santé
- Procédures chirurgicales, opératoires
- Gestion des soins aux patients
- Soins périopératoires
- Planification des soins aux patients
- Soins de santé complets
- Récupération améliorée après la chirurgie
- Voies critiques
Autres numéros d'identification d'étude
- CMUH115-REC3-148
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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