Prospective Study to Evaluate the Performance and the Safety of Global D's Implants of Craniomaxillofacial Surgery (CMF) Ranges Indicated for Trauma Surgery
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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Lyon、法国
- Hopital Femme Mère Enfant - Hospices Civils de Lyon (FRANCE)
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Lyon、法国
- Hopital de la Croix Rousse - Hospices Civils de Lyon (FRANCE)
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
The study population is composed of male and female, major or minor, who will be treated for trauma surgery. The patients have maxillary, mandibular or maxillomandibular fractures with/without annex skull's or face's fractures.
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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 for trauma surgery. |
Major or minor participants who will be treated for a trauma surgery with ORTRAUTEK® or MINITEK/MICROTEK® implant(s). |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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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
大体时间：6 months
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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). |
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Performance of the Global D implants used for trauma surgery - Outcome Measure 1
大体时间：6 months
|
Evolution of functional jaw activity, assessed by the evolution of MFIQ questionnaire's answers at 3 timepoints (pre-operative, 4-6 weeks after the surgery and 6 months after the surgery). The post-operatives answers will be compared to the pre-operative answers. |
6 months
|
|
Security of the Global D implants used for trauma surgery - Outcome Measure 2
大体时间：6 months
|
Adverse events identification, assessment and follow-up. |
6 months
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Security of the Global D implants used for trauma surgery - Outcome Measure 3
大体时间：6 months
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Bone consolidation after the surgery, 4-6 weeks after the surgery and 6 months after the surgery. |
6 months
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Performance of the Global D implants used for trauma surgery - Outcome Measure 4
大体时间：6 months
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Evolution of the patient's buccal quality of life at 3 timepoints: preoperative, 4-6 weeks after the surgery and 6 months after the surgery. The patient will answer the "Oral Health Impact Profile (OHIP-14)" questionnaire. This questionnaire is composed of 14 questions, the patient can answer from 0 (Never) to 4 (Very Often). |
6 months
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Surgeon satisfaction on the implant's utilisation - Outcome Measure 5
大体时间：Immediately following surgery
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Assessment by a satisfaction questionnaire, specially developed for the study, completed by the surgeon after the surgery. The surgeon evaluates each item using a likert scale (Highly Satisfied/ Satisfied/ Unsatisfied/Very Unsatisfied) |
Immediately following surgery
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Localisation and annex fractures data collection
大体时间：6 months
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If applicable, localisation and annex fractures data collection, and the medical device's references used to treat thoses fractures. |
6 months
|
合作者和调查者
赞助
调查人员
- 首席研究员：Julie Chauvel-Picard, MD、Cranio-maxillofacial surgeon
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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