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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
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Lyon、フランス
- Hopital Femme Mère Enfant - Hospices Civils de Lyon (FRANCE)
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Lyon、フランス
- Hopital de la Croix Rousse - Hospices Civils de Lyon (FRANCE)
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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). |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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
時間枠：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). |
6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Performance of the Global D implants used for trauma surgery - Outcome Measure 1
時間枠：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
時間枠：6 months
|
Adverse events identification, assessment and follow-up. |
6 months
|
|
Security of the Global D implants used for trauma surgery - Outcome Measure 3
時間枠：6 months
|
Bone consolidation after the surgery, 4-6 weeks after the surgery and 6 months after the surgery. |
6 months
|
|
Performance of the Global D implants used for trauma surgery - Outcome Measure 4
時間枠：6 months
|
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
|
|
Surgeon satisfaction on the implant's utilisation - Outcome Measure 5
時間枠：Immediately following surgery
|
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
|
|
Localisation and annex fractures data collection
時間枠：6 months
|
If applicable, localisation and annex fractures data collection, and the medical device's references used to treat thoses fractures. |
6 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Julie Chauvel-Picard, MD、Cranio-maxillofacial surgeon
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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