• OBJECTIVES
    • We sought to determine whether the use of the Reamer-Irrigator-Aspirator (RIA) device resulted in a decreased amount of fat emboli compared with standard reaming (SR) when performing intramedullary (IM) nailing of femoral shaft fractures.
  • DESIGN
    • Prospective randomized clinical trial.
  • SETTING
    • Multi-centered trial, level I trauma centers.
  • PATIENTS/PARTICIPANTS
    • All eligible patients who presented to participating institutions with an isolated femoral shaft fracture amenable to fixation with antegrade IM nailing. Thirty-one patients were enrolled: nine were excluded because of technical difficulties with the transesophageal echocardiogram (TEE) recording. Therefore, the study comprised 22 patients: 11 patients randomized to the SR group and eleven patients randomized to the RIA group.
  • INTERVENTION
    • Antegrade IM nailing of a femoral shaft fracture with standard reamers or the RIA device. All patients were monitored intraoperatively with a continuous TEE to assess embolic events in the right atrium. A radial arterial line was used to monitor blood gases and potential systemic effects of emboli.
  • MAIN OUTCOME MEASURE
    • Duration, size, and severity of emboli as measured by TEE. The operative procedure was divided into 6 distinct stages: preoperative, reduction, guidewire passage, reaming, nail insertion, and postoperative.
  • RESULTS
    • There was no significant difference in emboli between the RIA and SR groups preoperatively, during fracture reduction, guidewire insertion, or postoperatively. Measured with a standardized scoring system, there was a modest reduction in total emboli score in the RIA group during reaming (SR 5.30 [SD; 1.81] vs. RIA 4.05 [SD; 2.19], P = 0.005) and during nail insertion (SR 5.09 [SD; 1.74] vs. RIA 4.25 [SD; 1.89], P = 0.03). We were unable to correlate this reduction with any improvement in physiologic parameters (mean arterial pressure, end-tidal CO2, O2 saturation, pH, paO2, and paCO2).
  • CONCLUSIONS
    • This study showed a modest reduction of embolic debris during the reaming and nail insertion segments of the operative procedure. We were unable to correlate this with any change in physiologic parameters.
  • LEVEL OF EVIDENCE
    • Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.