A Multicentre Randomized Controlled Trial Comparing Plating with Intramedullary Nailing for Extra-articular Distal Tibial Fractures
2020
Abstract Background The aim of this randomized control trial is to examine the clinical outcomes for distal tibial fractures managed with IMN compared to those managed with plate fixation, to further elucidate the most optimum management. Method This was a multicentre randomized controlled trial recruited patients 18 years and older sustaining a closed, isolated extra-articular distal tibial fracture from 16/10/2015 to 20/03/2019. Open fractures, polytrauma or too distal fracture to achieve fixation of four cortices with distal interlocking screws for intra-medullary nailing were excluded. The primary outcome was the disability rating index (DRI) assessed at 12 months, whereas secondary outcomes were the SF-12 health questionnaire and Olerud-Molander Ankle Score (OMAS). The data were collected at 3 months, 6 months, 9 months, and 12 months, respectively. An independent t-test was performed for continuous data, whereas, for the analysis of categorical data, a Fisher exact test or a chi-square test was performed. The power of the study was kept at 90% with a p-value of less than 0.05 marked as significant. Results There were no significant differences in DRI score between the two managements at 12 months (P>0.05). Although there was a statistically significant difference in DRI score at 6 months in favour of plate fixation (P 0.05). Those managed with IMN reported a significantly higher SF-12 score than those managed with plate fixation at 12 months (P 0.05). Furthermore, those managed with IMN experienced a significantly higher incidence of delayed union and malunion in comparison to those managed with plate fixation (P Conclusion There is no significant difference in disability between the two managements at 12 months. Patients managed with IMN reported a significantly better overall health at 12 months via the SF-12 questionnaire.
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