A total of 254 patients with high-energy open tibia fractures were randomized to receive modern ring external fixation (n=122) or internal fixation (n=132). The primary outcome was rehospitalization or same day surgery for at least 1 of 6 major limb complications (infection, amputation, non-union, malunion, loss of reduction and/or hardware failure, or soft-tissue problems). The results revealed that external fixation was associated with a significantly higher risk of at least 1 major limb complication within 1 year follow-up vs internal fixation (RD=20.9% [95%CI 8.3%, 32.8%]; p=0.002). No statistically significant difference in the risk of at least 1 deep surgical site infection was observed between the internal fixation and modern ring fixation groups (RD=-3.5% [95%CI -14.8%, 7.8%]; p=0.54).