Hemiarthroplasty or total elbow arthroplasty for unreconstructible distal humeral fractures in the elderly (hot elbow): A feasibility study

Abstract

This feasibility trial aims to assess the practicality of, and obtain preliminary data to inform, a definitive randomised controlled trial (RCT) of total elbow arthroplasty (TEA) versus distal humeral hemiarthroplasty (HA) in patients over the age of 65 years with unreconstructible distal humeral fractures (DHF). 17 patients met the inclusion criteria during the 18-month recruitment period from December 2020 until June 2022, and 15 (88%) consented to be randomised (recruitment rate: 0.7/month). Two patients withdrew from the study prior to surgery leaving 13 patients for analysis (retention rate: 87%). Seven patients were randomised to TEA and six patients to HA. 100% of patients were available for 12-month follow-up. A 10-point difference in favour of HA in DASH (44.5 vs. 54.2) and OES (31.6 vs. 21.3) was seen during 6-week follow-up, while no difference in patient-reported outcome measures was seen at 3- or 12-month follow-up. This study demonstrates feasibility of undertaking an RCT of TEA versus HA in patients over the age of 65 with unreconstructible DHF. Preliminary data corroborate with the ongoing clinical equipoise and support the requirement for a larger adequately powered RCT. This trial is registered in the US Clinical Trials Registry (https://clinicaltrials.gov/study/NCT04646798?cond=distal%20humeral%20fracture&rank=6) Clinical Trial ID: NCT04646798.