Indomethacin for heterotopic ossification prophylaxis following surgical treatment of elbow trauma: a randomized controlled trial

Background: Heterotopic ossification is a frequent complication following surgical treatment of elbow trauma. The use of indomethacin to prevent heterotopic ossification is reported in the literature; however, its effectiveness is controversial. The purpose of this random-ized, double-blind, placebo-controlled study was to determine whether indomethacin is effective in reducing the incidence and severity of heterotopic ossification after surgical management of elbow trauma.Methods: Between February 2013 and April 2018, 164 eligible patients were randomized to receive postoperative indomethacin or pla-cebo medication. The primary outcome was the incidence of heterotopic ossification on elbow radiographs at 1-year follow-up. Second-ary outcomes included the Patient Rated Elbow Evaluation score, Mayo Elbow Performance Index score, and Disabilities of the Arm, Shoulder and Hand score. Range of motion, complications, and nonunion rates were also obtained.Results: At 1-year follow-up, there was no significant difference in the incidence of heterotopic ossification between the indomethacin group (49%) and the control group (55%) (relative risk, 0.89; P = .52). There were no significant differences in postoperative Patient Rated Elbow Evaluation, Mayo Elbow Performance Index, and Disabilities of the Arm, Shoulder and Hand scores or range of motion (P = .16). The complication rate was 17% in both the treatment and control groups (P > .99). There were no nonunions in either group.Conclusion: This Level I study demonstrated that indomethacin prophylaxis against heterotopic ossification in the setting of surgically treated elbow trauma was not significantly different from placebo. Level of evidence:Level I; Randomized Controlled Trial; Treatment Study (c) 2023 Journal of Shoulder and Elbow Surgery Board of Trustees. All rights reserved.