Surgery for Olecranon Fractures in the Elderly (SOFIE): Results of the SOFIE Randomized Controlled Trial.

Background: The financial and resource burden of management of olecranon fractures in the elderly is likely to increase with an aging population. There is limited evidence guiding treatment choice in this cohort. This study aimed to determine whether operative treatment of displaced olecranon fractures in elderly patients provides superior 12-month functional outcomes compared to nonoperative treatment.

Methods: A multicenter pragmatic randomized controlled trial was conducted across 24 hospitals in Australia and New Zealand. Patients aged ≥75 years presenting with an acute (within 14 days), displaced, closed, isolated olecranon fracture were included. Operative treatment involved reduction and stabilization using tension band wiring or plate fixation. Nonoperative treatment consisted of a sling for comfort and early movement as tolerated. The primary outcome was the Disabilities of the Arm, Shoulder and Hand (DASH) score at 12 months. Secondary outcomes were the DASH score at 3 months and pain, quality of life, Mayo Elbow Performance Score (MEPS), active elbow range of motion, and complication rate at 3 and 12 months. Data were analyzed based on an intention-to-treat principle, with sensitivity analyses using as-treated groups.

Results: Sixty participants were randomized, 27 to the operative group (mean age and standard deviation [SD], 83 ± 5.8 years; 22 [81%] females) and 33 to the nonoperative group (mean age, 82 ± 4.5 years; 23 [70%] females), with no significant difference in baseline characteristics. There was no significant difference (mean difference, -6.6; 95% confidence interval [CI] = -14.9 to 1.8; p = 0.12) in the mean DASH scores at 12 months (the primary outcome) between the operative (12.3 ± 14) and nonoperative (18.9 ± 18) groups. Although active elbow extension was significantly superior in the operative group at 12 months, no other secondary outcome differed significantly between groups at 12 months.

Conclusions: The study found no significant difference in DASH scores at 12 months between the operative and nonoperative groups. This supports nonoperative treatment as a reasonable option for displaced stable olecranon fractures in elderly patients.

Level of evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.