Trauma Injury Clinical Trial
Official title:
Prospective Study to Evaluate the Performance (by the Assessment of Patient's Mandibular Function) and the Safety of Global D's Implants of Cranio-maxillofacial Surgery Indicated for Trauma Surgery (CMF-TRAUMA)
Verified date | June 2024 |
Source | Global D |
Contact | Nathalie TRETOUT |
Phone | +33478569700 |
n.tretout[@]globald.com | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 102 |
Est. completion date | December 2025 |
Est. primary completion date | September 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 11 Years and older |
Eligibility | Inclusion Criteria: - Male or female patient, major or minor (11 years old minimum) - Patient having first facial trauma surgery (maxillary, mandibular or maxillomandibular fractures with/without annex skull's or face's fractures) - 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 |
Country | Name | City | State |
---|---|---|---|
France | Hopital de la Croix Rousse - Hospices Civils de Lyon (FRANCE) | Lyon | |
France | Hopital Femme Mère Enfant - Hospices Civils de Lyon (FRANCE) | Lyon |
Lead Sponsor | Collaborator |
---|---|
Global D |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | Performance of the Global D implants used for trauma surgery - Outcome Measure 1 | 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 | |
Secondary | Security of the Global D implants used for trauma surgery - Outcome Measure 2 | Adverse events identification, assessment and follow-up. | 1 year | |
Secondary | Security of the Global D implants used for trauma surgery - Outcome Measure 3 | Bone consolidation after the surgery, 4-6 weeks after the surgery and 6 months after the surgery. | 6 months | |
Secondary | Performance of the Global D implants used for trauma surgery - Outcome Measure 4 | Evolution of the patient's buccal quality of life in preoperative, 4-6 weeks after the surgery and 6 months after the surgery. To assessed this buccal quality of life, the patient will answered to 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 | |
Secondary | Surgeon satisfaction on the implant's utilisation - Outcome Measure 5 | 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 | |
Secondary | Localisation and annex fractures data collection | If applicable, localisation and annex fractures data collection, and the medical device's references used to treat thoses fractures. | 12 months |
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