Prospective Study to Evaluate the Performance and the Safety of Global D's Implants of Craniomaxillofacial Surgery (CMF) Ranges Indicated for Trauma Surgery (CMF-TRAUMA)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 99
- 试验地点
- 4
- 主要终点
- Performance of the Global D's implants used for trauma surgery assessed by the evaluation of the functional jaw activity 6 months after the surgery
研究概览
简要总结
This study is set up within the framework of the European Union regulation 2017/745 on medical devices. Its objective is to confirm the performance and safety of the Global D implants (ORTRAUTEK® and MINITEK/MICROTEK®) used for trauma surgery.
详细描述
Study design : Non-interventional, prospective, multicentric, national, open-label, non-comparative study.
Investigators : 5 sites in France.
A statistical evaluation will be performed on those data in order to determine the performance and the security of those devices.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 11 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient, major or minor (11 years old minimum)
- •Patient undergoing surgery on the mandible and/or maxilla (mandatory), with or without associated facial fractures (orbit, upper two-thirds of the face, skull)
- •Patient with abilities to read, understand and answer to the study questionnaires.
- •Patient (and his legal representative if minor) who signed the study consent form.
- •Patient affiliated to a social security system.
排除标准
- •Patient allergic to one of the components of the implants
- •Patient with physical or mental inabilities that will compromise the follow-up during the study
- •Patient with acute or chronic infection (local or systemic)
- •Patients with bone's tumors in the anchorage area of the implant
- •Person on legal protection
- •Pregnant or breastfeeding women
研究组 & 干预措施
Study group
Male and female, major or minor patients. The patients have maxillary, mandibular, maxillomandibular fracture with/without annex face or skull fracture, and will be treated by trauma surgery.
干预措施: Trauma surgery using Global D's implants. (Device)
结局指标
主要结局
Performance of the Global D's implants used for trauma surgery assessed by the evaluation of the functional jaw activity 6 months after the surgery
时间窗: 6 months
The functional jaw activity will be evaluated with the Mandibular Function Impairment Questionnaire (MFIQ) 6 months after the surgery. This questionnaire have 17 items, that have to be answered with a Likert scale from 1 (No problem) to 5 (very hard or impossible).
次要结局
- Performance of the Global D implants used for trauma surgery - Outcome Measure 1(6 months)
- Security of the Global D implants used for trauma surgery - Outcome Measure 2(1 year)
- Security of the Global D implants used for trauma surgery - Outcome Measure 3(6 months)
- Surgeon satisfaction on the implant's utilisation - Outcome Measure 5(Immediately following surgery)
- Performance of the Global D implants used for trauma surgery - Outcome Measure 4(6 months)
- Localisation and annex fractures data collection(12 months)