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Axelrod D, Johal H, Madden K, Marcano F, Prada C.2019. Fracture Table vs. Lateral Positioning for Intramedullary Fixation of Femur Fractures (The FLiP Study): A protocol for a pilot randomized controlled trial. PeerJ Preprints7:e27875v2https://doi.org/10.7287/peerj.preprints.27875v2
Background: Femoral Shaft fractures are devastating and life threatening injuries. Femoral shaft fractures are most commonly treated with intramedullary fixation. Malrotation of the injured limb after fixation is a common and significant complication following femoral shaft fractures. During the operation, patients can be positioned either supine or in a lateral position. Additionally, patients can be placed on a standard radiolucent operating room table, or placed on a fracture table with traction statically applied to the operative limb throughout the case. Previous case series and cohort studies have shown equivalence between study groups, but choice between positioning options remains controversial.
Methods: This represents a protocol for a randomized controlled pilot trial. We will be compared lateral positioning with use of manual traction to supine positioning with use of a fracture table. Primary outcomes will be in assessment for feasibility for a future full scale randomized trial, including evaluating patient recruitment, patient compliance with followup, contamination between treatment arms and others.
Results: The primary outcome will be feasibility for a future trial. Secondary outcomes will include malrotation as measured through postoperative computed tomography scans and gait analysis at 6 months.
We have updated our protocol with more detail regarding our cluster crossover trial methodology. Also, we have decreased the amount of secondary outcomes, removing intraoperative SF-12 scores while replacing them with EQ5D scores for ease of use.
Schematic and image of patient in the lateral position
View of the patient after draping in lateral position