Fracture Table vs. Lateral Positioning for Antegrade Intramedullary Fixation of Femur Fractures (The FLiP Study): The Clinical Outcomes of a Multi-Centre Cluster Randomized Crossover Pilot Study.

Abstract

Objectives: To determine whether patient positioning supine on a fracture table (SFT) or laterally on a radiolucent table (LRT) reduced the risk of clinically important femoral malrotation in patients undergoing antegrade intramedullary fixation for femoral shaft fractures.

Design: A pilot multicentre, prospective cluster randomized crossover trial.

Setting: Three orthopaedic trauma centres.

Patient selection criteria: Patients over 18 years of age with femoral shaft fractures (AO/OTA 32-A, 32-B, or 32-C) appropriate for antegrade intramedullary fixation.Outcome Measures and Comparison: The primary clinical outcome was rotational alignment of the operative limb measured through a bilateral postoperative computed tomography (CT) scan, using the uninjured limb as a reference. Secondary clinical outcomes included quality of life, mobility, operative time, fluoroscopy use, need for open reduction, use of reduction adjuncts, associated positioning complications, hospital stay, and ventilator support days.

Results: A total of 101 patients were enrolled, with 54 randomized to SFT and 47 randomized to LRT. There were 26 females (48.1%) in the SFT group and 27 females (57.4%) in the LRT group. The mean age was 60.2 years (SD 25.8 years) in the SFT group and 62.7 years (SD 27.6 years) in LRT group. Most fractures resulted from falls (59.3% SFT; 66% LRT), were subtrochanteric (63% SRT; 61.7% LRT), and classified as simple AO/OTA 32-A (53.7% SRT; 53.2% LRT). Femoral malrotation >15° occurred in 20 (37.7%) SFT and 9 (19.1%) LRT participants The odds of femoral malrotation of ≥15° were 2.6 times higher in the SFT group (95% Confidence Interval 1.0 to 6.4; p=0.04). In both groups, patients were more likely to have an external rotation deformity compared to their native anatomy, with external rotation more common in SFT (69.8% versus 59.6%; p=0.17). No secondary outcomes reached statistical significance (P>0.05).

Conclusions: In this clinical outcome assessment of patients enrolled in a feasibility trial, patients treated with SFT were more likely to have femoral malrotation after femoral shaft fracture fixation than patients treated with LRT.

Level of evidence: Level 2.