両顎手術に適応したグローバルDインプラントの性能と安全性を評価する研究 (CMF-ORTHO)
両顎手術を適応とする頭蓋顎顔面外科手術のグローバル D インプラントのパフォーマンス (患者の生活の質の評価による) と安全性を評価するための前向き研究
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
Nantes、フランス、44000
- CHU de Nantes
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
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 by orthognatic surgery (maxillary, mandibular, maxillomandibular or/with genioplasty). The bone maturity of the participants (assessed by investigators) need to be sufficient for the treatment.
説明
Inclusion Criteria:
- 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.
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)
- 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, 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. |
Major or minor participants who will be treated by an orthognathic surgery with ORTRAUTEK® or MINITEK® 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 orthognathic surgery, assessed by the Orthognathic Quality of Life Questionnaire (OQLQ) before and after the surgery.
時間枠：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). |
1 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Surgeon satisfaction on the implant's utilisation
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/ Not very satisfied / Unsatisfied). |
Immediately following surgery
|
|
Security of the Global D implants used for orthognathic surgery - Outcome Measure 1a
時間枠：6 weeks after the surgery
|
Bone consolidation after the surgery, assessed by a correct dental occlusion on the postoperative image. This information is assessed 6 weeks after the surgery: correct occlusion (Yes/No). |
6 weeks after the surgery
|
|
Security of the Global D implants used for orthognathic surgery - Outcome Measure 1b
時間枠：6 weeks after the surgery
|
Bone consolidation after the surgery, assessed by the alimentation of the patient. This information is assessed 6 weeks after the surgery: solid alimentation of the patient (Yes/No). |
6 weeks after the surgery
|
|
Security of the Global D implants used for orthognathic surgery - Outcome Measure 2
時間枠：18 months
|
Adverse events identification, assessment and follow-up. |
18 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Pierre CORRE, 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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。