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Current data show smoking is associated with a number of complications of the fracture healing process. A concern, however, is the potential confounding effect of covariates associated with smoking. The present study is the first to prospectively examine time to union, as well as major complications of the fracture healing process, while adjusting for potential confounders.Eight Level I trauma centers.Patients with unilateral open tibia fractures were divided into 3 baseline smoking categories: never smoked (n = 81), previous smoker (n = 82), and current smoker (n = 105).Time to fracture healing, diagnosis of infection, and osteomyelitis.Survival and logistic analyses were used to study differences in time to fracture healing and the likelihood of developing complications, respectively. Multivariate models were used to adjust for injury severity, treatment variations, and patient characteristicsAfter adjusting for covariates, current and previous smokers were 37% (P = 0.01) and 32% (P = 0.04) less likely to achieve union than nonsmokers, respectively. Current smokers were more than twice as likely to develop an infection (P = 0.05) and 3.7 times as likely to develop osteomyelitis (P = 0.01). Previous smokers were 2.8 times as likely to develop osteomyelitis (P = 0.07), but were at no greater risk for other types of infection.Smoking places the patient at risk for increased time to union and complications. Previous smoking history also appears to increase the risk of osteomyelitis and increased time to union. The results highlight the need for orthopaedic surgeons to encourage their patients to enter a smoking cessation programs.