Universal Surgical Device for Mandibular Reconstruction Using Fibula Free Flap : Feasibility Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Feasibility of guiding mandibular fibula free flap reconstruction with an universal guide.
研究概览
简要总结
Fibula free flap is the gold standard for mandibular reconstruction. The shape of the fibula requires osteotomy that can be performed with a custom surgical guide. The use of surgical guide shorten surgical time, enhances the precision of the surgeon and reduces morbidity.
Since 2008 custom surgical guide have been used in the hospital department and the clinical team have noticed a number of elements, which leads investigator to think that it would be possible to perform this kind of procedure using an universal guide.
The aim of this study is to assess the possibility to perform mandibular fibula free flap reconstruction with an universal guide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Admitted in the maxillofacial surgery department for mandibular fibula free flap reconstruction including a symphysial bone fragment
- •Patients insured under the French social security system
- •Free and informed consent
排除标准
- •Lateral mandibular reconstruction without symphysis reconstruction
- •Legally incompetent
- •Inclusion in another protocol of research , involving mandibular reconstruction
- •Pregnant or breastfeeding women
研究组 & 干预措施
Group experimental
The patients included in the study and admitted in the maxillofacial surgery department for mandibular fibula free flap reconstruction will benefit from a surgery assisted with the universal surgical device FIBUMAND.
干预措施: Universal surgical device FIBUMAND (Device)
结局指标
主要结局
Feasibility of guiding mandibular fibula free flap reconstruction with an universal guide.
时间窗: Day 1
Either the surgeon assists the entire procedure using the device and the patient is registered as "success", or the device is not suitable and cannot be used and the patient is registered as " failure ". Partial use is also considered a failure of the procedure.
次要结局
- Qualitative assessment of the device by the surgeon(Day 1)
- Post-operative quality of life(From 6 to 8 weeks)
- Time of surgical procedure(Day 1)