Injury - 2026-04-01 - Journal Article; Randomized Controlled Trial
Randomized prospective study on the treatment of extra-articular fractures of the distal tibia with intramedullary locked nails with or without simultaneous fibula fixation.
de Camargo Leonhardt M, Leonhardt NZ, Dos Santos Silva J, Kojima KE
Topics
Key Takeaway
Concomitant fibular fixation in extra-articular distal tibial fractures treated with IMN showed no significant difference in malunion (11.8% vs 18.6%), nonunion (5.9% vs 4.7%), or functional outcomes at one year.
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Summary
This RCT compared IMN alone versus IMN with concomitant fibular fixation for displaced extra-articular distal tibial fractures (including Gustilo IIIA open fractures) in patients aged 18–60. Primary outcomes were union by modified RUST score ≥11, malalignment on radiograph and CT at one year, Lysholm and AOFAS functional scores, and complication rates. No statistically significant differences were found in any primary or secondary outcome between groups.
Key Limitation
The study is underpowered — with only 77 patients and malunion rates of 11.8–18.6%, the trial lacks sufficient sample size to exclude a clinically meaningful difference in alignment outcomes.
Original Abstract
BACKGROUND
Extra-articular distal tibial fractures treated with locked intramedullary nails present a high rate of malunion, particularly rotational deformities. Concomitant fibular fixation has been associated with a reduction in malalignment; however, some studies suggest it may increase nonunion and complication rates, including infection. There is currently no consensus regarding the influence of fibular stabilization in these fractures.
OBJECTIVE
To compare radiographic outcomes, functional results, and complication rates of extra-articular distal tibial fractures treated with locked intramedullary nails, with or without concomitant fibular fixation.
METHODS
A randomized prospective study was conducted including patients aged 18-60 years with displaced extra-articular distal tibial fractures, including open fractures up to Gustilo type IIIA, associated with fibular fractures located below the middle third. Patients lost to follow-up or who did not complete all radiographic or functional assessments were excluded. Primary outcomes included fracture union assessed by a modified RUST score ≥ 11 at 12 months, malalignment assessed by postoperative radiographs and CT scan at one year, functional evaluation of the knee and ankle using the Lysholm and AOFAS scores, respectively, and complication rates.
RESULTS
At the end of follow-up, 43 patients without fibular fixation (HIMB group) and 34 with fixation (HIMBF group) were analyzed. The nonunion rate was 4.7 % in the HIMB group and 5.9 % in the HIMBF group, with no significant difference. Fracture healing progression was similar between groups. Malunion occurred in 18.6 % of the HIMB group and 11.8 % of the HIMBF group, without statistical significance. There were no significant differences in complication rates or in knee and ankle functional outcomes at one year.
CONCLUSION
Concomitant fibular fixation does not influence nonunion or malunion rates, does not increase complication rates, and does not affect knee or ankle function in the treatment of extra-articular distal tibial fractures stabilized with locked intramedullary nails.