MULTISITE CLINICAL TRIAL OF RIGID/VS WIRE FIXATION

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DESCRIPTION: This is a proposal requesting three more years of funding for a clinical trial comparing rigid and wire fixation. The objective of this ongoing randomized clinical trial is to compare the efficacy and cost-effectiveness of these two most commonly used surgical stabilization procedures when used in the most common orthognathic procedure - mandibular advancement. Secondary objectives are to identify patient risk factors and describe the complications associated with these two procedures. These objectives are being accomplished through a multisite randomized clinical trial involving patients who were randomized to receive wire or rigid fixation. By the end of existing funding period, these patients will complete a 2-year follow-up. The present proposal is for completion of a 5-year follow-up for a set of 98 patients from 2 of the 3 centers involved in the current study. Assessment of the 2-year data showed trends in surgical, functional and psychosocial outcomes. The addition of follow-up to 5 years is anticipated to clarify these trends. The trial will have 80 percent power to detect clinically meaningful differences between the groups on all primary outcomes. Treatment differences relate to measures of stability of the surgical outcome, neurosensory function, masticatory performance, quality of life, patient satisfaction and cost effectiveness.