Mandibular Slotplates
试验速览
- 阶段
- 不适用
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Feasebility of the slotprinciple
研究概览
简要总结
A new osteosynthesis system for orthognathic surgery was proposed.This system allows small intra-operative adjustments of the bone fragments during the osteosynthesis phase of the operation (also known as the slot principle). Another possible advantage are the slant screw holes with chamfered ridges allowing easy placements of the screws via the small incision wound without undercuts in between the plate and the screwheads.
详细描述
Initial slotplates were developed for Le Fort I osteotomies, zygoma 'sandwich 'osteotomies and genioplasties. Those plates allowed for the slot principle to be performed during orthognathic surgery. Mandibular slotplates for bilateral sagittal split osteotomy (BSSO) were recently designed. The aim of the study is to evaluate their clinical usefulness and the applicability of the slot principle with these plates in BSSO.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing single osteotomy BSSO surgery
排除标准
- •Concomitant surgeries at the same time.
研究组 & 干预措施
Mandibular slotplate
Mandibular slotplates are placed during BSSO surgery and their clinical usefullness is tested. Afterwards the plates are removed and the osteotomy is fixated by three bicortical screws.
干预措施: Mandibular slotplate (Device)
结局指标
主要结局
Feasebility of the slotprinciple
时间窗: during surgery
yes or no
Inclination of the screws
时间窗: during surgery
Useful yes or no
次要结局
未报告次要终点
研究者
Veerle Van Mossevelde
Director
Universitair Ziekenhuis Brussel