Effect of Locking Plate Fixation vs Intramedullary Nail Fixation on 6-Month Disability Among Adults With Displaced Fracture of the Distal Tibia: The UK FixDT Randomized Clinical Trial.

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.

OBJECTIVE

To assess disability, quality of life, and complications in patients with displaced tibial fracture treated with intramedullary nail fixation vs locking plate fixation.

DESIGN, SETTING, AND PARTICIPANTS: 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.

INTERVENTIONS

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.

MAIN OUTCOMES AND MEASURES

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).

RESULTS

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], P = .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], P < .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], P = .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).

CONCLUSIONS AND RELEVANCE

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.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: ISRCTN99771224.