Combination of Rigid and Nonrigid Fixation Versus Nonrigid Fixation for Bilateral Mandibular Fractures: A Multicenter Randomized Controlled Trial
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Combination of Rigid and Nonrigid Fixation Versus Nonrigid Fixation for Bilateral Mandibular Fractures: A Multicenter Randomized Controlled Trial. / Rughubar, Vivesh; Vares, Yan; Singh, Priyadeshni; Filipsky, Anton; Creanga, Adrian; Iqbal, Syed; Alkhalil, Moustafa; Kormi, Eeva; Hanken, Henning; Calle, Alvaro Rivero; Smolka, Wenko; Turner, Michael; Csáki, Gábor; Sánchez-Aniceto, Gregorio; Pérez, Daniel; Cornelius, Carl-Peter; Alani, Belal; Vlad, Daniel; Kontio, Risto; Ellis, Edward.
in: J ORAL MAXIL SURG, Jahrgang 78, Nr. 10, 10.2020, S. 1781-1794.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Combination of Rigid and Nonrigid Fixation Versus Nonrigid Fixation for Bilateral Mandibular Fractures: A Multicenter Randomized Controlled Trial
AU - Rughubar, Vivesh
AU - Vares, Yan
AU - Singh, Priyadeshni
AU - Filipsky, Anton
AU - Creanga, Adrian
AU - Iqbal, Syed
AU - Alkhalil, Moustafa
AU - Kormi, Eeva
AU - Hanken, Henning
AU - Calle, Alvaro Rivero
AU - Smolka, Wenko
AU - Turner, Michael
AU - Csáki, Gábor
AU - Sánchez-Aniceto, Gregorio
AU - Pérez, Daniel
AU - Cornelius, Carl-Peter
AU - Alani, Belal
AU - Vlad, Daniel
AU - Kontio, Risto
AU - Ellis, Edward
N1 - Copyright © 2020 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.
PY - 2020/10
Y1 - 2020/10
N2 - 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.
AB - 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.
KW - Adult
KW - Bone Plates
KW - Fracture Fixation
KW - Fracture Fixation, Internal
KW - Humans
KW - Jaw Fixation Techniques
KW - Mandible
KW - Mandibular Fractures/diagnostic imaging
KW - Treatment Outcome
U2 - 10.1016/j.joms.2020.05.012
DO - 10.1016/j.joms.2020.05.012
M3 - SCORING: Journal article
C2 - 32589939
VL - 78
SP - 1781
EP - 1794
JO - J ORAL MAXIL SURG
JF - J ORAL MAXIL SURG
SN - 0278-2391
IS - 10
ER -