NCT00213837已完成2 期
Reconstruction Implant Bone (Anterior Mandibular Arch) After Removing Using Porous Titanium Prosthesis in ENT Surgery
University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2003年10月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- TEP scan + MRI + CT scan
研究概览
简要总结
This trial will study the reconstruction of the anterior part of the mandible and the adjacent soft tissue parts by a mandibular prosthesis made in porous titanium, associated or not, to a latissimus dorsi or pectoral flap, to avoid reconstruction with free microanastomosed bone flaps that are often associated with important morbidity.
The implant is consolidated by two prolonged parallel plates of titanium, allowing their fixation to the bone, easy to fix in a short time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female more than 18 years old
排除标准
- •Age less than 18 years old
- •Pregnant women
- •Local carcinoma excluding radiotherapic or surgical control
- •Poor general condition
- •Contraindication to general anesthesia
- •Uncontrolled diabetes
结局指标
主要结局
TEP scan + MRI + CT scan
时间窗: 3 months after surgery
Blood analysis (interleukin)
时间窗: 8, 15, 30 days and 3 months after surgery
All types of complication
时间窗: 8, 15, 30 days, 3, 6 months after surgery and then every 6 months during the whole trial
次要结局
未报告次要终点
研究者
研究点 (1)
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