Objective: To compare the rate of Acute Respiratory Distress Syndrome (ARDS) in multiply injured patients with femoral shaft fractures, treated with intramedullary femoral nails inserted with or without reaming.
Design: Prospective, randomized, multicenter, clinical trial.
Setting: Seven Level 1 trauma centers.
Patients: Three hundred fifteen patients with 322 femoral shaft fractures were stratified into 2 groups according to their estimated injury severity scores (ISS > or =18 vs. ISS<18) and then randomized to receive an IM nail with either reamed or unreamed insertion for primary stabilization of their femoral shaft fracture. One hundred forty seven patients with 151 fractures received an unreamed nail whereas 168 patients with 171 fractures, received a reamed nail. All fractures were nailed within 24 hours after their trauma.
Intervention: Closed intramedullary nailing for femoral shaft fractures.
Main outcome measurements: Determination of the rate of ARDS in patients undergoing intramedullary nailing of femoral shaft fractures.
Results: Three of the 63 multiply injured patients who received a reamed nail developed ARDS as compared with 2 out of 46 patients in the unreamed group. This difference was not statistically significant (P=0.42). (The power for this difference is only 5%. 39,817 patients are needed in each group to detect a difference that small.) This difference was not statistically significant. There were a total of 4 deaths, 2 each in both the reamed and unreamed group. No death resulted from ARDS.
Conclusions: The overall incidence of ARDS was found to be low with primary stabilization of femoral shaft fractures with intramedullary nailing. There was no difference in the incidence of ARDS between the reamed and unreamed groups, given the sample size.