Postoperative Outcomes Within Enhanced Recovery After Surgery Protocol in Elective Total Hip and Knee Arthroplasty. POWER.2 Study: Study Protocol for a Prospective, Multicentre, Observational Cohort Study
Javier Ripollés-Melchor, Ane Abad-Motos, Margarita Logroño-Egea, César Aldecoa, José Antonio García-Erce, Ignacio Jiménez-López, Concepción Cassinello-Ogea, Oliver Marín-Peña, Carlos Ferrando-Ortolá, Alejandro Suárez de la Rica, Manuel A Gómez-Ríos, Rubén Sánchez-Martín, Alfredo Abad-Gurumeta, Rubén Casans-Francés, Ana Mugarra-Llopis, Marina Varela-Durán, Javier Longás-Valién, Álvaro Ramiro-Ruiz, Ana B Cuellar-Martínez, José M Ramírez-Rodríguez, José M Calvo-Vecino, Javier Ripollés-Melchor, Ane Abad-Motos, Margarita Logroño-Egea, César Aldecoa, José Antonio García-Erce, Ignacio Jiménez-López, Concepción Cassinello-Ogea, Oliver Marín-Peña, Carlos Ferrando-Ortolá, Alejandro Suárez de la Rica, Manuel A Gómez-Ríos, Rubén Sánchez-Martín, Alfredo Abad-Gurumeta, Rubén Casans-Francés, Ana Mugarra-Llopis, Marina Varela-Durán, Javier Longás-Valién, Álvaro Ramiro-Ruiz, Ana B Cuellar-Martínez, José M Ramírez-Rodríguez, José M Calvo-Vecino
Abstract
Objective: The number of indications for total hip replacement (THR) and total knee replacement (TKR) surgery is increasing. Enhanced recovery after surgery (ERAS) represents the next step in the evolution of standardised care. The primary aim of this study is to measure the in-hospital 30-day medical and surgical postoperative complications rate. The study's secondary aims are to determine the length of stay, 30-day mortality rate, 30-day reoperation and readmission rates, the ERAS overall compliance and predefined ERAS individual items compliance.
Methods: This multicentre, prospective, observational study will include adult patients (aged >18 years) undergoing elective THR and TKR surgery. Consecutive patients undergoing surgery within the 2-month data collection period will be included. Centres that offer the THR and/or TKR surgery will be eligible to participate. The data collection will be done through an online data collection form via a secure, password-protected platform at each centre with predefined data fields.
Results: Ethical approval for this study has been obtained from the Comité de Ética de la Investigación de la Comunidad Autónoma de Aragón (C.P.-C.I. PI18/135; on 23 May 2018). It was prospectively registered on 27 June 2018, at www.clinicaltrials.gov with identification no. NCT03570944.
Conclusion: The study will be disseminated through the SPARN-RedGERM, SEDAR, GERM and through social media. Peer-reviewed publications will be published under corporate authorship, including POWER.2 Study Group and SPARN-RedGERM.
Keywords: Arthroplasty; arthroplasty; follow-up studies; hip; knee; outcome and process assessment (health care); replacement.
Conflict of interest statement
Conflict of Interest: JRM reports grants from the SPARN-RedGERM during the study, and personal fees and non-financial support from Edwards Lifesciences and from Fresenius Kabi outside the submitted work. JAGE reports grants and personal fees from Vifor Uriach; personal fees from Zambon; grants, personal fees and non-financial support from Amgen; grants and personal fees from Jansen and grants from Roche during the study. In addition, JAGE reports non-financial support from Terumo, Immucor and Celgene; grants and personal fees from Octapharma and grants from BCL Behring outside the submitted work. CCO reports personal fees from Fresenius Kabi, Medtronic and Vifor-Pharma outside the submitted work. AAG reports personal fees and non-financial support from MSD and from Braun, personal fees from Altan and from Ferrer outside the submitted work. OMP reports personal fees from DePuy-Synthes-Johnson & Johnson, Exactech, Heraeus and 3M; grants from Stryker and grants from Arthrex outside the submitted work. AAM, MLE, CA, IJL CFO, ASR, RCF, AML, MGR, RSM, MVD, JLV, ARR, ACM, JRR and JCV made no statements.
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Source: PubMed