Prospective cohort study comparing a triceps-sparing and triceps-detaching approach in total elbow arthroplasty: a protocol.

Autor: Meijering D; Department of Orthopedic Surgery, University Medical Center Groningen, Groningen, The Netherlands d.meijering@umcg.nl., Boerboom AL; Department of Orthopedic Surgery, University Medical Center Groningen, Groningen, The Netherlands., Gerritsma CLE; Department of Orthopaedic Surgery, Martini Hospital, Groningen, The Netherlands., The B; Department of Orthopedic Surgery, Amphia Hospital, Breda, The Netherlands., van den Bekerom MPJ; Department of Orthopedic Surgery, OLVG, Amsterdam, The Netherlands.; Department of Human Movement Sciences, Faculty of Behavioral and Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands., van der Pluijm M; Department of Orthopedic Surgery, Sint Maartenskliniek, Nijmegen, The Netherlands., Vegter RJK; Department of Human Movement Sciences, University of Groningen, Groningen, The Netherlands., Bulstra SK; Department of Orthopedic Surgery, University Medical Center Groningen, Groningen, The Netherlands., Eygendaal D; Department of Orthopedic Surgery, Amphia Hospital, Breda, The Netherlands.; Department of Orthopedic Surgery, Amsterdam Universitair Medische Centra, Amsterdam, The Netherlands., Stevens M; Department of Orthopedic Surgery, University Medical Center Groningen, Groningen, The Netherlands.
Jazyk: angličtina
Zdroj: BMJ open [BMJ Open] 2021 May 05; Vol. 11 (5), pp. e046098. Date of Electronic Publication: 2021 May 05.
DOI: 10.1136/bmjopen-2020-046098
Abstrakt: Background: New surgical approaches have been developed to optimise elbow function after total elbow arthroplasty (TEA). Currently, there is no consensus on the best surgical approach. This study aims to investigate the functional outcomes, prosthetic component position and complication rates after a triceps-sparing and a triceps-detaching approach in TEA.
Methods and Analysis: A multicentre prospective comparative cohort study will be conducted. All patients with an indication for primary TEA will enrol in either the triceps-sparing or the triceps-detaching cohort. Primary outcome measure is elbow function, specified as fixed flexion deformity. Secondary outcome parameters are self-reported and objectively measured physical functioning, including triceps force, prosthetic component position in standard radiographs and complications.
Discussion: The successful completion of this study will clarify which surgical approach yields better functional outcomes, better prosthetic component position and lower complication rates in patients with a TEA.
Ethics and Dissemination: The Medical Ethics Review Board of University Medical Center Groningen reviewed the study and concluded that it is not clinical research with human subjects as meant in the Medical Research Involving Human Subjects Act (WMO), therefore WMO approval is not needed (METc2019/544).
Trial Registration Number: NTR NL8488.
Competing Interests: Competing interests: DE disclosed the following financial relationships with commercial entities that produce healthcare-related products or services: institutional research support, Matthys; institutional research support, Zimmer-Biomet; institutional research support, Stryker; speaker/teacher for AO and IBRA courses; advisory board member for Lima Corporates. None related to this manuscript.
(© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)
Databáze: MEDLINE