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Indomethacin Prophylaxis for Heterotopic Ossification after Acetabular Fracture Surgery Increases the Risk for Nonunion of the Posterior Wall

Sagi, H. Claude MD, FACS*; Jordan, Charles J. MD*; Barei, David P. MD; Serrano-Riera, Rafael MD*; Steverson, Barbara RN, MHA*

Journal of Orthopaedic Trauma: July 2014 - Volume 28 - Issue 7 - p 377–383
doi: 10.1097/BOT.0000000000000049
Original Article
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Objectives: To determine if indomethacin has a positive clinical effect for the prophylaxis of heterotopic ossification (HO) after acetabular fracture surgery. To determine whether indomethacin affects the union rate of acetabular fractures.

Design: Prospective randomized double-blinded trial.

Setting: Level 1 regional trauma center.

Patients: Skeletally mature patients treated operatively for an acute acetabular fracture through a Kocher–Langenbeck approach.

Intervention: Patients were randomly allocated to 1 of 4 groups comparing placebo (group 1) to 3 days (group 2), 1 week (group 3), and 6 weeks (group 4) of indomethacin treatment.

Main Outcome Measurements: Factors analyzed included the overall incidence, Brooker class and volume of HO, radiographic union of the acetabular fracture, and pain. Patients were followed clinically and radiographically at 6 weeks, 3 months, 6 months, and 1 year. Serum levels of indomethacin were drawn at 1 month to assess compliance. Computed tomographic scans were performed at 6 months to assess healing and volume of HO.

Results: Ninety-eight patients were enrolled into this study, 68 completed the follow-up and had the 6-month computed tomographic scan, and there was a 63% compliance rate with the treatment regimen. Overall incidence of HO was 67% for group 1, 29% for group 2 (P = 0.04), 29% for group 3 (P = 0.019), and 67% for group 4. The volume of HO formation was 17,900 mm3 for group 1, 33,800 mm3 for group 2, 6300 mm3 for group 3 (P = 0.005), and 11,100 mm3 for group 4. The incidence of radiographic nonunion was 19% for group 1, 35% for group 2, 24% for group 3, and 62% for group 4 (P = 0.012). Seventy-seven percent of the nonunions involved the posterior wall segment. Pain visual analog scores (VASs) were significantly higher for patients with radiographic nonunion (VAS 4 vs. VAS 1, P = 0.002).

Conclusions: Treatment with 6 weeks of indomethacin does not appear to have a therapeutic effect for decreasing HO formation after acetabular fracture surgery and appears to increase the incidence of nonunion. Treatment with 1 week of indomethacin may be beneficial for decreasing the volume of HO formation without increasing the incidence of nonunion.

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

*Orthopaedic Trauma Service, Florida Orthopaedic Institute, Tampa, FL; and

Department of Orthopaedic Surgery, Harborview Medical Center, Seattle, WA.

Reprints: H. Claude Sagi, MD, FACS, Orthopaedic Trauma Service, Florida Orthopaedic Institute, Tampa General Hospital, 5 Tampa General Circle, Suite 710, Tampa, FL 33606 (e-mail: eversosaggy@me.com).

The authors report no conflict of interest.

Supported through a grant provided by the Orthopedic Research and Education Foundation.

Presented in part at the Annual Meeting of the Orthopaedic Trauma Association, October 2012, Minneapolis, MN.

Accepted September 12, 2013

© 2014 by Lippincott Williams & Wilkins