양악수술 적응증 글로벌 D임플란트의 성능 및 안전성 평가 연구 (CMF-ORTHO)
양악수술에 적응증이 되는 두개악안면외과의 Global D's Implant의 성능(환자의 삶의 질 평가에 의한) 및 안전성을 평가하기 위한 전향적 연구
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Nantes, 프랑스, 44000
- CHU de Nantes
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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). |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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.
기간: 1 year
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Surgeon satisfaction on the implant's utilisation
기간: 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/ Not very satisfied / Unsatisfied). |
Immediately following surgery
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Security of the Global D implants used for orthognathic surgery - Outcome Measure 1a
기간: 6 weeks after the surgery
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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
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Security of the Global D implants used for orthognathic surgery - Outcome Measure 1b
기간: 6 weeks after the surgery
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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
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Security of the Global D implants used for orthognathic surgery - Outcome Measure 2
기간: 18 months
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Adverse events identification, assessment and follow-up. |
18 months
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Pierre CORRE, MD, Cranio-maxillofacial surgeon
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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