Effect of locking plate fixation versus intramedullary nail fixation for adult patients with a displaced fracture of the distal tibia : a randomised controlled trial (UK FixDT)

Importance: 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. Objectives: To assess disability, quality of life and complications in patients treated with intramedullary nail fixation versus locking plate fixation. Design, Setting and Participants: This was a multi-centre randomised trial; 321 adult patients were recruited from April 2013 with final follow-up February 2017. Exclusions; open fractures, fractures involving the ankle joint, contraindication to nailing or inability to complete questionnaires. Interventions: Nail fixation (n=161), a metal rod is inserted into the hollow centre of the tibia, versus locking plate fixation (n=160), a plate is attached to the surface of the tibia with fixed-angle screws. Main outcome measures: Disability Rating Index (DRI), 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 was also collected at 3 and 12 months. Secondary outcomes were the Olerud and Molander Ankle Score (OMAS), quality of life, complications such as infection, and further surgery. Results: Participants had a mean age of 45 years (standard deviation =16.2), were predominantly male (61%, N=197/321) and had experienced traumatic injury after a fall (69%, 223/321). There was no statistically significant difference in the DRI at 6 months: nail group mean 29.8 (95% CI 26.1 to 33.7) and plate group mean 33.8 (95% CI 29.7 to 37.9); adjusted difference 4.0 [95%CI -1.0 to 9.0],p=0.11). There was a statistically significant difference in the DRI at 3 months in favour of nail fixation (mean 44.2 (95% CI 40.8 to 47.6) and plate group 52.6 (95% CI 49.3 to 55.9); adjusted difference 8.8, [95% CI 4.3 to 13.2],p<0.001), but not at 12 months (nail group 23.1 (95% CI 18.9 to 27.2) and plate group 24.0 (95% CI 19.7 to 28.3); adjusted difference 1.9 [95%CI -3.2 to 6.9],p=0.47). Secondary outcomes showed the same pattern, including a statistically significant difference in mean OMAS scores at 3 and 6 months in favour of nail fixation. There were no statistically significant differences in complications, including the number of post-operative infections (13% in plate group and 9% in nail group).Further surgery was more common in the locking plate group (12% in plate group and 8% in nail group at 12 months). Conclusions and Relevance: Among adults with an acute fracture of the distal tibia randomized to nail fixation or locking plate fixation, there were similar disability ratings at 6 months. Other factors may need to be considered in deciding the optimal approach.