Fracture table vs. lateral positioning for intramedullary fixation of femur fractures (The FLiP Trial): the feasibility of a cluster randomized crossover trial.
Daniel E Axelrod, Sheila Sprague, Ernesto Guerra-Farfan, Yaiza Garcia-Sanchez, Brad Meulenkamp, Melanie Dodd-Moher, Sofia Bzovsky, Christy Shibu, Gina Del Fabbro, Jodi L Gallant, Thomas Mammen, Herman Johal
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引用次数: 0
Abstract
Background: Femoral shaft fractures are common severe injuries that carry an elevated risk of operative complications, including femoral malrotation, neurologic, and vascular injuries. There is no definitive research comparing two commonly used surgical tables and patient positions in aiding with both reduction and fixation of femoral shaft fractures. The objective of this pilot trial was to test the feasibility of a cluster randomized crossover trial that assesses the comparative effectiveness of supine positioning on a fracture table versus lateral positioning on a radiolucent table for antegrade intramedullary fixation of femoral shaft fractures.
Methods: Three orthopaedic trauma centres participated in this pilot trial. Each clinical site was randomized to a starting position, crossed over to the other treatment after 2 months, and alternated treatments in this fashion for the length of the trial. During the enrolment phase, we assessed compliance, enrolment rates, participant follow-up, and accurate documentation of the primary clinical outcome. The feasibility success criteria were: (1) 90% enrolment of eligible participants during enrolment phases; (2) 90% compliance with the trial interventions as per the cluster randomization crossover scheme; (3) timely collection of primary outcome data (i.e., within 6 weeks of fracture) in 95% of participants, (4) 90% completion of participant follow-up data; and (5) definition of the primary outcome as a categorical variable with an appropriate threshold value. Feasibility outcomes were summarized using descriptive statistics reported as means (standard deviation) or medians (first quartile, third quartile) for continuous variables depending on their distribution and counts (percentage) for categorical variables.
Results: All five of the criteria for feasibility were met. Of the 110 eligible patients identified at the three clinical sites, 101 (91.8%) were enroled over a 2.5-year period and 95/101 (94.1%) received the correct cluster-assigned treatment. The primary outcome (malrotation measured on the CT) was accurately documented within 6 weeks of fracture for 98% of participants (99/101) with 93 participants completing the final follow-up (92.0%). Lastly, the trial data informed an appropriate threshold, a malrotation cut off of 15°, for the primary outcome in the definitive trial.
Conclusions: These results confirm the feasibility of a definitive trial comparing patient positioning during intramedullary fixation of femoral shaft fractures using a cluster randomized crossover trial design. However, due to funding limitations, a slower than anticipated enrolment, and concerns with surgical equipoise, this trial did not proceed to the definitive phase.
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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