Modern External Ring Fixation Versus Internal Fixation for Treatment of Severe Open Tibial Fractures: A Randomized Clinical Trial (FIXIT Study)

Abstract

Background: Modern external ring fixation has been hypothesized to reduce complications requiring hospital readmission compared with internal fixation when treating patients with high-energy open tibial shaft fractures. In this study, the 1-year probability of a major limb complication was compared between external and internal fixation of severe open tibial fractures.

Methods: This multicenter randomized clinical trial included patients 18 to 64 years of age with severe open tibial shaft fractures randomly assigned to either modern external ring fixation (n = 127) or internal fixation (n = 133). The primary outcome was a major limb complication within 365 days after randomization; these complications included amputation, infection, a soft-tissue problem, nonunion, malunion, and a loss of reduction/implant failure.

Results: Of 260 randomized patients, 254 were included in the final analysis. Their mean age (standard deviation) was 39 (13) years; 214 (84%) were men. The probability of at least 1 major limb complication was higher for external fixation (62.1% [95% confidence interval (CI): 53.4% to 70.8%]) than internal fixation (43.7% [95% CI: 35.5% to 52.9%]), with a risk difference of 18.4% (95% CI: 5.8% to 30.4%); p = 0.005). The most notable difference was in loss of reduction/implant failure, the rate of which was higher for external fixation (risk difference: 14.4% [95% CI: 7.0% to 21.6%]; p = 0.002). There was no appreciable difference in the probability of deep infection between external fixation (26.1%) and internal fixation (29.7%) (risk difference: -3.5% [95% CI: -14.8% to 7.8%]; p = 0.54). There were also no appreciable differences in the probabilities of amputation, nonunion, soft-tissue problems, malunion, or fracture healing between the groups.

Conclusions: These results argue against routine use of modern external ring fixation for the treatment of these severe open tibial fractures.

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