Elbow hemiarthroplasty versus open reduction and internal fixation for AO/OTA type 13 C2 and C3 fractures of distal humerus in patients aged 50 years or above: a randomized controlled trial

BACKGROUND: Intraarticular distal humeral fractures of AO/OTA type 13 C2 and C3 pose a surgical challenge despite the evolution of surgical implants and techniques. Open reduction and internal fixation (ORIF) is often preferred as the first choice of treatment, but the results vary and are sometimes disappointing. Total elbow arthroplasty (TEA) has been widely used for fractures that are not amenable to ORIF in elderly patients, but the mechanical complications remain a challenge, especially in active patients. Elbow hemiarthroplasty (EHA) provides a modern alternative that might avoid the mechanical complications and weight bearing restrictions related to the linked articulation in semi-constrained TEA. No studies have compared the results of EHA to that of ORIF, but case series have reported promising results. METHODS/DESIGN: This is a study protocol describing an investigator-initiated, non-blinded randomized controlled trial comparing the outcome of EHA with ORIF for AO/OTA type 13 C2 and C3 fractures of the distal humerus in patients who are 50 years or older. Forty-four patients with AO/OTA type 13 C2 and C3 fractures of distal humerus will be randomized to either EHA or ORIF. The Oxford Elbow Score (OES) will be used as primary outcome. Mayo Elbow Performance Score (MEPS), pain severity score (VAS), range of motion, and patient satisfaction will be used as secondary outcomes. Reoperations, complications, and the length of sick leave will be recorded. The patients will be examined after the operation and at 3 months and 1, 2, 5, and 10 years. DISCUSSION: The main objective of this study is to investigate the best treatment option for AO/OTA type 13 C2 and C3 fractures of distal humerus in patients aged 50 years or above. We hypothesize that EHA results in fewer complications and superior functional outcome compared with ORIF and that the mechanical complications related to the linked articulation of TEA can be avoided. TRIAL REGISTRATION: ClinicalTrials.gov, PRS, NCT04163172. Registered November 13, 2019. https://clinicaltrials.gov/ct2/results?cond=&term=evori&cntry=&state=&city=&dist= (Table 2). The protocol has been approved by The Scientific Ethics Committee of the Capital Region of Denmark (Jr. no.: H(− 19,035,590)). The processing of personal data has been approved by the Danish Data Protection Agency (Jr. no. P-2019-246). Inclusion started on February 1, 2020.