OBJECTIVE To evaluate the safety and efficacy of early NovaBone grafting in accelerating healing of high-energy tibial shaft fractures. METHODS In a prospective, randomized, controlled study 78 patients with open or closed tibial shaft fractures were treated with reamed interlocking nails, combined with NovaBone grafting. Forty patients were randomly assigned to the experimental group (with NovaBone grafting at fracture site), and 38 to the control group (without NovaBone grafting). RESULTS All patients were followed up for an average of 8 months (range 6-18 months). The average fracture healing time was 12 weeks (range 8-16 weeks) in the experimental group, and 19 weeks (range 12-36 weeks) in the control group (P < 0.01). No delayed union or nonunion was found in the experimental group, but four cases (10.5%) in the control group were found to heal spontaneously between 7 and 8 months. When the data were analyzed at week 12 and week 26 according to the criteria of Johner and Wruhs, 88% and 100% of the cases in the experimental group were rated as excellent and good respectively, but in the control group, 50% and 89% were rated as excellent and good respectively, these being significant differences (P < 0.05). CONCLUSIONS Internal fixation supplemented with early prophylactic NovaBone grafting of high-energy tibial shaft fractures is a safe and effective treatment which accelerates fracture healing.