PAPER 6: A RANDOMIZED TRIAL OF REAMED VERSUS NON-REAMED INTRAMEDULLARY NAIL INSERTION ON RATES OF RE-OPERATION IN PATIENTS WITH FRACTURE OF THE TIBIA

Abstract

Winner of ISFR Best Paper Award

Introduction: Surgeons agree on the benefits of intramedullary nailing of tibial shaft fractures. We assessed the impact of reamed versus unreamed intramedullary nailing on re-operation rates.

Methods: The Study to Prospectively Evaluate Reamed Intamedullary Nails in Tibial Fractures (SPRINT) was a multi-center, randomized trial including 29 clinical sites. 1339 patients with tibial shaft fractures were randomized to either reamed or unreamed intramedullary nail insertion. Re-operations before 6 months were not permitted unless there was critical bone loss. The primary outcome was re-operation to promote healing, treat infection, or preserve the limb. We planned a priori to conduct a subgroup analysis of outcomes in patients with open and closed fractures.

Results: Of 1339 enrolled patients, 1226 patients were followed to 1 year. Across treatment groups, patients did not differ in age, gender, and fracture types. The overall event rate was 17.8% (13.7% closed, 27%, open fractures). In 826 patients with closed fractures, patients with a reamed nail had a relative risk reduction of 33% (95%CI: 4–53%, P=0.03). This treatment effect was largely driven by differential autodynamization rates (rel risk: 0.42, p=0.01). Among 400 patients with open fractures, there was a trend towards an increased risk of an event (rel. risk=1.27, p=0.16) for those who received a reamed nail.

Conclusions: Our overall incidence of revision surgery was lower than reported in previous studies. Optimizing peri-operative care and avoiding premature re-operation may substantially decrease the need for re-operation in tibial fracture patients.