Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT05742932
Status:
RECRUITING
Last Update Posted:
2025-11-25
First Post:
2023-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Study to Evaluate the Performance and the Safety of Global D's Implants of Craniomaxillofacial Surgery (CMF) Ranges Indicated for Trauma Surgery (CMF-TRAUMA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081084', 'term': 'Accidental Injuries'}, {'id': 'D008440', 'term': 'Maxillary Fractures'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007572', 'term': 'Jaw Fractures'}, {'id': 'D008446', 'term': 'Maxillofacial Injuries'}, {'id': 'D005151', 'term': 'Facial Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012887', 'term': 'Skull Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 102}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2023-02-15', 'studyFirstSubmitQcDate': '2023-02-15', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "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", 'timeFrame': '6 months', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Performance of the Global D implants used for trauma surgery - Outcome Measure 1', 'timeFrame': '6 months', 'description': "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."}, {'measure': 'Security of the Global D implants used for trauma surgery - Outcome Measure 2', 'timeFrame': '1 year', 'description': 'Adverse events identification, assessment and follow-up.'}, {'measure': 'Security of the Global D implants used for trauma surgery - Outcome Measure 3', 'timeFrame': '6 months', 'description': 'Bone consolidation after the surgery, 4-6 weeks after the surgery and 6 months after the surgery.'}, {'measure': 'Performance of the Global D implants used for trauma surgery - Outcome Measure 4', 'timeFrame': '6 months', 'description': "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)."}, {'measure': "Surgeon satisfaction on the implant's utilisation - Outcome Measure 5", 'timeFrame': 'Immediately following surgery', 'description': '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)'}, {'measure': 'Localisation and annex fractures data collection', 'timeFrame': '12 months', 'description': "If applicable, localisation and annex fractures data collection, and the medical device's references used to treat thoses fractures."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Performance', 'Safety', 'Screw', 'Plate', 'Medical device', 'Trauma surgery', 'Cranio-maxillofacial', 'Global D'], 'conditions': ['Trauma Injury', 'Maxilla Fracture', 'Maxillofacial Trauma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Study design : Non-interventional, prospective, multicentric, national, open-label, non-comparative study.\n\nInvestigators : at least 6 sites in France.\n\nA statistical evaluation will be performed on those data in order to determine the performance and the security of those devices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '11 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The study population is composed of male and female, major or minor, who will be treated by trauma surgery. The patients will have maxillary, mandibular or maxillomandibular fractures with/without annex skull's or face's fractures.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female patient, major or minor (11 years old minimum)\n* Patient having first facial trauma surgery (maxillary, mandibular or maxillomandibular fractures with/without annex skull's or face's fractures)\n* Patient with abilities to read, understand and answer to the study questionnaires.\n* Patient (and his legal representative if minor) who signed the study consent form.\n* Patient affiliated to a social security system.\n\nExclusion Criteria:\n\n* Patient allergic to one of the components of the implants\n* Patient with physical or mental inabilities that will compromise the follow-up during the study\n* Patient with acute or chronic infection (local or systemic)\n* Patients with bone's tumors in the anchorage area of the implant\n* Person on legal protection\n* Pregnant or breastfeeding women"}, 'identificationModule': {'nctId': 'NCT05742932', 'briefTitle': "Prospective Study to Evaluate the Performance and the Safety of Global D's Implants of Craniomaxillofacial Surgery (CMF) Ranges Indicated for Trauma Surgery (CMF-TRAUMA)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Global D'}, 'officialTitle': "Prospective Study to Evaluate the Performance and the Safety of Global D's Implants of Craniomaxillofacial Surgery (CMF) Ranges Indicated for Trauma Surgery (CMF-TRAUMA)", 'orgStudyIdInfo': {'id': '2102-G-CMF-TRAUMA-R'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': '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 by trauma surgery.', 'interventionNames': ["Device: Trauma surgery using Global D's implants."]}], 'interventions': [{'name': "Trauma surgery using Global D's implants.", 'type': 'DEVICE', 'description': 'Major or minor participants who will be treated by an trauma surgery with ORTRAUTEK® or MINITEK/MICROTEK® implant(s).', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mathieu Daurade, MD', 'role': 'CONTACT'}], 'facility': 'Hopital de la Croix Rousse - Hospices Civils de Lyon (FRANCE)', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julie Chauvel-Picard, MD', 'role': 'CONTACT'}], 'facility': 'Hopital Femme Mère Enfant - Hospices Civils de Lyon (FRANCE)', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'Victor DOLIGEZ', 'role': 'CONTACT', 'email': 'v.doligez@globald.com', 'phone': '+33 (0)6 24 17 39 02'}], 'overallOfficials': [{'name': 'Julie Chauvel-Picard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cranio-maxillofacial surgeon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Global D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}