Prospective Study to Evaluate the Performance (by the Assessment of Patient's Quality of Life) and the Safety of Global D's Implants of Cranio-maxillofacial Surgery Indicated for Orthognathic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Performance of the Global D's implants used for orthognathic surgery, assessed by the Orthognathic Quality of Life Questionnaire (OQLQ) before and 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®) used for orthognathic surgery.
详细描述
Study design : Non-interventional, prospective, multicentric, national, open-label, non-comparative study.
Investigators : 7 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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient, major or minor, having reached bone maturity according to the judgement of the investigator,
- •Patient having first orthognathic surgery (maxillary, mandibular, maxillomandibular or/with genioplasty)
- •Patient who received orthodontic treatment prior to orthognathic surgery.
- •Patient with abilities to read, understand and answer to the study quality of life questionnaire.
- •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)
- •Person on legal protection
- •Pregnant or breastfeeding women
研究组 & 干预措施
Study group
Male and female, major or minor, who will be treated by orthognathic surgery (maxillary, mandibular, maxillomandibular or/with genioplasty). The bone maturity of the participants (assessed by investigators) need to be sufficient for the treatment.
干预措施: Orthognathic surgery using Global D's implants. (Device)
结局指标
主要结局
Performance of the Global D's implants used for orthognathic surgery, assessed by the Orthognathic Quality of Life Questionnaire (OQLQ) before and after the surgery.
时间窗: 1 year
The evolution of patient's quality of life will be assessed by comparing the score of the Orthognathic Quality of Life Questionnaire (OQLQ) before and after the surgery. The OQLQ can vary from 0 (better quality of life) to 88 (worst quality of life).
次要结局
- Surgeon satisfaction on the implant's utilisation(Immediately following surgery)
- Security of the Global D implants used for orthognathic surgery - Outcome Measure 2(18 months)
- Security of the Global D implants used for orthognathic surgery - Outcome Measure 1b(6 weeks after the surgery)
- Security of the Global D implants used for orthognathic surgery - Outcome Measure 1a(6 weeks after the surgery)
- Security of the Global D implants used for orthognathic surgery - Outcome Measure 3(12 months)