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

Abstract

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. 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. 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. These results argue against routine use of modern external ring fixation for the treatment of these severe open tibial fractures. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.