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.

METHODS: From January 2013 till March 2018, a total of 55 patients with acute unilateral closed midshaft clavicle fracture were treated with either a 3.5-mm pre-contoured LCP [32 patients; 25 men and 7 women; mean age: 35 years (range: 19-63 years)] or a 3.5-mm nonlocked reconstruction plate [23 patients; 20 men and 3 women; mean age: 31.4 years (range: 17-61 years)]. The clinical outcomes in terms of fracture union, Quick Disability of Arm, Shoulder and Hand (DASH) score, implant irritation, failure rate, and reoperation rate were evaluated retrospectively. The patient billing records were reviewed to obtain primary operation, reoperation, and total operative cost for midshaft clavicle fracture. These values were analyzed and converted from Malaysia Ringgit (RM) to United States Dollar (USD) at the exchange rate of RM 1 to USD 0.24. All patients were followed up for at least one-year duration.

RESULTS: The mean time to fracture union, implant irritation, implant failure, and reoperation rate showed no significant difference between the two groups of patients. The mean Quick DASH score was significantly better in the reconstruction plate group with 13 points compared with 28 points in the LCP group (p=0.003). In terms of total operative cost, the LCP group recorded a cost of USD 391 higher than the reconstruction plate group (p<0.001).

CONCLUSION: The 3.5-mm reconstruction plate achieved not only satisfactory clinical outcomes but was also more cost-effective than the LCP in the treatment of displaced midshaft clavicle fractures.