Undersøgelse, der evaluerer ydeevnen og sikkerheden af globale D-implantater, der er indiceret til ortognatisk kirurgi (CMF-ORTHO)
Prospektiv undersøgelse til evaluering af ydeevnen (ved vurdering af patientens livskvalitet) og sikkerheden af globale D's implantater af kranio-maxillofacial kirurgi indiceret til ortognatisk kirurgi
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.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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-
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Nantes, Frankrig, 44000
- CHU de Nantes
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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.
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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). |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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.
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Surgeon satisfaction on the implant's utilisation
Tidsramme: 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
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Security of the Global D implants used for orthognathic surgery - Outcome Measure 1a
Tidsramme: 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
Tidsramme: 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
Tidsramme: 18 months
|
Adverse events identification, assessment and follow-up. |
18 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Pierre CORRE, MD, Cranio-maxillofacial surgeon
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Muskuloskeletale sygdomme
- Stomatognatiske sygdomme
- Sygdomme i nervesystemet
- Sår og skader
- Brud, Knogle
- Kraniofaciale abnormiteter
- Muskuloskeletale abnormiteter
- Stomatognatiske systemabnormiteter
- Medfødte abnormiteter
- Kraniocerebralt traume
- Traumer, nervesystemet
- Ansigtsskader
- Kæbebrud
- Kæbeskader
- Kraniebrud
- Medfødte, arvelige og neonatale sygdomme og abnormiteter
- Kæbefrakturer
- Maxillofacial abnormiteter
Andre undersøgelses-id-numre
- 2101-G-CMF-ORTHO-R
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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