Sagi, J Orthop Trauma 2014 - Indomethacin Prophylaxis for Heterotopic Ossification after Acetabular Fracture Surgery Increases the Risk for Nonunion of the Posterior Wall - Article Summary

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

Sagi, Steverson, et al.·J Orthop Trauma·2014·109 citations·RCT

Purpose

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.

Methods

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 Measures:

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

98 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 mm for group 1, 33,800 mm for group 2, 6300 mm for group 3 (P = 0.005), and 11,100 mm 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).
77 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. Copyright remains with the authors and publisher.

Core

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