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

ABSTRACT

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.