Combination of Rigid and Nonrigid Fixation Versus Nonrigid Fixation for Bilateral Mandibular Fractures: A Multicenter Randomized Controlled Trial

Vivesh Rughubar, Yan Vares, Priyadeshni Singh, Anton Filipsky, Adrian Creanga, Syed Iqbal, Moustafa Alkhalil, Eeva Kormi, Henning Hanken, Alvaro Rivero Calle, Wenko Smolka, Michael Turner, Gábor Csáki, Gregorio Sánchez-Aniceto, Daniel Pérez, Carl Peter Cornelius, Belal Alani, Daniel Vlad, Risto Kontio, Edward Ellis

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

Purpose: We aimed to compare complication rates and functional outcomes in patients with bilateral mandibular fractures treated with different degrees of internal fixation rigidity. Patients and Methods: This international, multicenter randomized controlled trial included adults with bilateral mandibular fractures located at either the angle and body, angle and symphysis, or body and symphysis. Patients were treated with either a combination of rigid fixation for the anterior fracture and nonrigid fixation for the posterior fracture (mixed fixation) or nonrigid fixation for both fractures. The primary outcome was complications within 6 weeks after surgery. Secondary outcomes were complications within 3 months, Helkimo dysfunction index, and mandibular mobility at 6 weeks and 3 months after surgery. Results: Of the 315 patients enrolled, 158 were randomized to the mixed fixation group and 157 to the nonrigid fixation group. The overall complication rate at 6 weeks in the intention-to-treat population was 9.6% (95% confidence interval [CI], 5.3% to 15.6%) in the mixed fixation group and 7.8% (95% CI, 4.0% to 13.5%) in the nonrigid fixation group. With an unadjusted odds ratio of 1.25 (95% CI, 0.51 to 3.17), there were no statistically significant differences in complication rates between the 2 groups (P =.591). A multivariable model for complication risk at 6 weeks found no significant differences between treatment groups, but patients with moderate or severe displacement had a higher complication rate than those with no or minimal displacement (adjusted odds ratio, 4.58; 95% CI, 1.16 to 18.06; P =.030). There were no significant between-group differences in complication rates at 3 months. Moreover, no significant differences in Helkimo dysfunction index and mandibular mobility index at 6 weeks and 3 months were found between groups according to treatment allocated and treatment received. Conclusions: A combination of rigid and nonrigid fixation in patients with bilateral mandibular fracture has similar complication rates and functional outcomes to nonrigid fixation for both fractures.

Original languageEnglish (US)
Pages (from-to)1781-1794
Number of pages14
JournalJournal of Oral and Maxillofacial Surgery
Volume78
Issue number10
DOIs
StatePublished - Oct 2020

ASJC Scopus subject areas

  • Surgery
  • Oral Surgery
  • Otorhinolaryngology

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