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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, Vol. 78, No. 10, 10.2020, p. 1781-1794.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Rughubar, V, Vares, Y, Singh, P, Filipsky, A, Creanga, A, Iqbal, S, Alkhalil, M, Kormi, E, Hanken, H, Calle, AR, Smolka, W, Turner, M, Csáki, G, Sánchez-Aniceto, G, Pérez, D, Cornelius, C-P, Alani, B, Vlad, D, Kontio, R & Ellis, E 2020, 'Combination of Rigid and Nonrigid Fixation Versus Nonrigid Fixation for Bilateral Mandibular Fractures: A Multicenter Randomized Controlled Trial', J ORAL MAXIL SURG, vol. 78, no. 10, pp. 1781-1794. https://doi.org/10.1016/j.joms.2020.05.012

APA

Rughubar, V., Vares, Y., Singh, P., Filipsky, A., Creanga, A., Iqbal, S., Alkhalil, M., Kormi, E., Hanken, H., Calle, A. R., Smolka, W., Turner, M., Csáki, G., Sánchez-Aniceto, G., Pérez, D., Cornelius, C-P., Alani, B., Vlad, D., Kontio, R., & Ellis, E. (2020). Combination of Rigid and Nonrigid Fixation Versus Nonrigid Fixation for Bilateral Mandibular Fractures: A Multicenter Randomized Controlled Trial. J ORAL MAXIL SURG, 78(10), 1781-1794. https://doi.org/10.1016/j.joms.2020.05.012

Vancouver

Rughubar V, Vares Y, Singh P, Filipsky A, Creanga A, Iqbal S et al. Combination of Rigid and Nonrigid Fixation Versus Nonrigid Fixation for Bilateral Mandibular Fractures: A Multicenter Randomized Controlled Trial. J ORAL MAXIL SURG. 2020 Oct;78(10):1781-1794. https://doi.org/10.1016/j.joms.2020.05.012

Bibtex

@article{df9ab96c42fb4bbf9d3a28be64e05b12,
title = "Combination of Rigid and Nonrigid Fixation Versus Nonrigid Fixation for Bilateral Mandibular Fractures: A Multicenter Randomized Controlled Trial",
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.",
keywords = "Adult, Bone Plates, Fracture Fixation, Fracture Fixation, Internal, Humans, Jaw Fixation Techniques, Mandible, Mandibular Fractures/diagnostic imaging, Treatment Outcome",
author = "Vivesh Rughubar and Yan Vares and Priyadeshni Singh and Anton Filipsky and Adrian Creanga and Syed Iqbal and Moustafa Alkhalil and Eeva Kormi and Henning Hanken and Calle, {Alvaro Rivero} and Wenko Smolka and Michael Turner and G{\'a}bor Cs{\'a}ki and Gregorio S{\'a}nchez-Aniceto and Daniel P{\'e}rez and Carl-Peter Cornelius and Belal Alani and Daniel Vlad and Risto Kontio and Edward Ellis",
note = "Copyright {\textcopyright} 2020 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.",
year = "2020",
month = oct,
doi = "10.1016/j.joms.2020.05.012",
language = "English",
volume = "78",
pages = "1781--1794",
journal = "J ORAL MAXIL SURG",
issn = "0278-2391",
publisher = "W.B. Saunders Ltd",
number = "10",

}

RIS

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 -