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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Lyon, Frankrig
- Hopital Femme Mère Enfant - Hospices Civils de Lyon (FRANCE)
-
Lyon, Frankrig
- Hopital de la Croix Rousse - Hospices Civils de Lyon (FRANCE)
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
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 for trauma surgery. The patients have maxillary, mandibular or maxillomandibular fractures with/without annex skull's or face's fractures.
Beskrivelse
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
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 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). |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Performance of the Global D implants used for trauma surgery - Outcome Measure 1
Tidsramme: 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
Tidsramme: 6 months
|
Adverse events identification, assessment and follow-up. |
6 months
|
|
Security of the Global D implants used for trauma surgery - Outcome Measure 3
Tidsramme: 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
Tidsramme: 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
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/ Unsatisfied/Very Unsatisfied) |
Immediately following surgery
|
|
Localisation and annex fractures data collection
Tidsramme: 6 months
|
If applicable, localisation and annex fractures data collection, and the medical device's references used to treat thoses fractures. |
6 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Julie Chauvel-Picard, 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
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2102-G-CMF-TRAUMA-R
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