MULTISITE CLINICAL TRIAL OF RIGID/VS WIRE FIXATION

刚性/VS 钢丝固定的多站点临床试验

• 批准号: 2015071
• 负责人: JOHN D RUGH
• 金额: $ 24.17万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 1990
• 资助国家: 美国
• 起止时间: 1990-07-01 至 1999-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2015071
• 关键词: arthrodesis; clinical research; clinical trials; health care cost /financing; human subject; mandible /maxilla; mastication; oral pharyngeal surgery; quality of life; satisfaction; temporomandibular joint syndrome

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.

说明：这是一项要求再提供三年资金的提案， 一项比较刚性和钢丝固定的临床试验。 的目的 正在进行的随机临床试验是比较疗效和 这两种最常用的手术稳定的成本效益 当用于最常见的正颌手术时-下颌 进步。 次要目的是识别患者风险因素， 描述与这两种手术相关的并发症。 这些 通过多中心随机临床试验， 涉及随机接受导丝或刚性导丝的患者的试验 固定 在现有的资助期结束时，这些患者将 完成2年随访。 目前的建议是完成一个 5-对来自3个中心中的2个中心的98例患者进行了1年随访 在目前的研究中。 对2年数据的评估显示， 手术、功能和心理社会结果。 增加后续行动 预计5年内将澄清这些趋势。 审判将有80名 检测组间有临床意义差异的把握度百分比 所有主要结果。 待遇差异与下列措施有关： 手术结果的稳定性，感觉神经功能，咀嚼功能 性能、生活质量、患者满意度和成本效益。