Study Evaluating the Performance and Safety of Global D Implants Indicated for Trauma Surgery (CMF-TRAUMA)

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05742932
• Other study ID #: 2102-G-CMF-TRAUMA-R
• Status: Recruiting
• Start date: March 7, 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2023
• Source: Global D
• Contact: Nathalie TRETOUT
• Phone: +33478569700
• Email: n.tretout[@]globald.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Study design : Non-interventional, prospective, multicentric, national, open-label, non-comparative study. Investigators : at least 6 sites in France. A statistical evaluation will be performed on those data in order to determine the performance and the security of those devices.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: December 2024
• Est. primary completion date: March 2024
• 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

Related Conditions & MeSH terms

• Maxillofacial Trauma
• Trauma Injury
• Wounds and Injuries

Intervention

Device:
• Trauma surgery using Global D's implants.
Major or minor participants who will be treated by an trauma surgery with ORTRAUTEK® or MINITEK/MICROTEK® implant(s).

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Global D

Country where clinical trial is conducted

France, 

Outcome

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