Effect of Locking Plate Fixation vs Intramedullary Nail Fixation on 6-Month Disability Among Adults With Displaced Fracture of the Distal Tibia
Authors: Matthew L. Costa, Juul Achten, James Griffin, Stavros Petrou, Ian Pallister, Sarah E. Lamb, Nick R. Parsons
Journal: JAMA (2017)

<h3>Importance</h3> The best treatment for fractures of the distal tibia remains controversial. Most such fractures require surgical fixation but outcomes are unpredictable and complications are common. <h3>Objective</h3> To assess disability, quality of life, and complications in patients with displaced tibial fracture treated with intramedullary nail fixation vs locking plate fixation. <h3>Design, Setting, and Participants</h3> A multicenter randomized trial recruiting 321 patients 16 years or older with an acute, displaced, extra-articular fracture of the distal tibia from April 2013 through April 2016 with final follow-up in February 2017. Exclusion criteria included open fractures, fractures involving the ankle joint, contraindication to nailing, or inability to complete questionnaires. <h3>Interventions</h3> Intramedullary nail fixation (nail group; n = 161), a metal rod inserted into the hollow center of the tibia, vs locking plate fixation (plate group; n = 160), a plate attached to the surface of the tibia with fixed-angle screws. <h3>Main Outcomes and Measures</h3> Disability Rating Index (DRI; score range, 0 [no disability] to 100 [complete disability]) at 6 months was the primary outcome measure, with a minimal clinically important difference of 8 points. DRI measurement was also collected at 3 and 12 months. Secondary outcomes were the Olerud-Molander Ankle Score (OMAS), quality of life, and complications (such as infection and further surgery). <h3>Results</h3> Among 321 randomized patients (mean age, 45 years [SD, 16.2]; men, 197 [61%]; had experienced traumatic injury after a fall, 223 [69%]), 258 completed the study. There was no statistically significant difference in the DRI score at 6 months between groups (mean score, 29.8 in the nail group vs 33.8 in the plate group; adjusted difference, 4.0 [95% CI, −1.0 to 9.0],<i>P</i> = .11). There was a statistically significant difference in the DRI score at 3 months in favor of nail fixation (mean score, 44.2 in the nail group and 52.6 in the plate group; adjusted difference, 8.8 [95% CI, 4.3 to 13.2],<i>P</i> &lt; .001), but not at 12 months (mean score, 23.1 in the nail group and 24.0 in the plate group; adjusted difference, 1.9 [95% CI, −3.2 to 6.9],<i>P</i> = .47). Secondary outcomes showed the same pattern, including a statistically significant difference in mean OMAS at 3 and 6 months in favor of nail fixation. There were no statistically significant differences in complications, including the number of postoperative infections (9% in the nail group vs 13% in the plate group). Further surgery was more common in the plate group at 12 months (8% in nail group vs 12% in plate group). <h3>Conclusions and Relevance</h3> Among patients 16 years or older with an acute, displaced, extra-articular fracture of the distal tibia, neither nail fixation nor locking plate fixation resulted in superior disability status at 6 months. Other factors may need to be considered in deciding the optimal approach. <h3>Trial Registration</h3> clinicaltrials.gov Identifier:ISRCTN99771224