Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-26 @ 9:59 PM
Study NCT ID:
NCT05073757
Status:
COMPLETED
Last Update Posted:
2025-07-30
First Post:
2021-08-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study to Evaluate the Performance and Safety of Custom-made Implants in Cranio-Maxillofacial (CMF) Surgery Indicated for Orthognathic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001860', 'term': 'Bone Plates'}], 'ancestors': [{'id': 'D016268', 'term': 'Internal Fixators'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D009984', 'term': 'Orthopedic Fixation Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D053831', 'term': 'Surgical Fixation Devices'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2021-08-04', 'studyFirstSubmitQcDate': '2021-10-08', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Orthognatic quality of life questionnaire', 'timeFrame': '12 months post-operatively', 'description': 'To evaluate the performance of custom-made implants indicated for orthognathic surgery by measuring the quality of life of patients'}], 'secondaryOutcomes': [{'measure': "Surgeon satisfaction on the implant's utilisation", '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/ Not very satisfied / Unsatisfied).'}, {'measure': 'Security of the implants used for orthognathic surgery', 'timeFrame': '12 months', 'description': 'Adverse events identification, assessment and follow-up.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['orthognatic surgery', 'guided surgery', '3D printing', 'plate', 'screw', 'custom-made'], 'conditions': ['Surgery', 'Orthognathic Surgery', 'Orthognathic Surgical Procedures']}, 'descriptionModule': {'briefSummary': 'With the digital age, guided surgery and cases of fully computer-assisted surgeries via 3D printing guides and preformed plates are booming.\n\nOur project aims to study the performance and safety of custom-made implants (custom-made guides and plates) in orthognathic surgery in order to obtain specific clinical data on SLS France devices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Orthognatic surgery male or female patients, adults or minors whose bone maturity is sufficient according to the judgment of the investigator.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patient, adult or minor having reached bone maturity according to the judgment of the investigator,\n* Patient having first orthognathic surgery with SLS France custom-made guides and plates,\n* Patient who received orthodontic treatment prior to orthognathic surgery,\n* Patient able to read, understand and answer the study quality of life questionnaire,\n* Patient (and legal representative if a minor) who is not opposed to his participation in the study or to the processing of his data.\n* Patient affiliated to a social insurance\n\nExclusion Criteria:\n\n* Patient allergic to one of the compounds of the plates and / or guides,\n* Patient with physical or mental disability making it impossible to follow up in the study,\n* Patient with significant expansion\n* Patient with a congenital craniofacial malformation\n* Patient with acute or chronic local or systemic infection,\n* Person placed under legal protection,\n* Pregnant or breastfeeding women.'}, 'identificationModule': {'nctId': 'NCT05073757', 'briefTitle': 'Prospective Study to Evaluate the Performance and Safety of Custom-made Implants in Cranio-Maxillofacial (CMF) Surgery Indicated for Orthognathic Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Global D'}, 'officialTitle': 'Prospective Study to Evaluate the Performance and Safety of Custom-made Implants in Cranio-Maxillofacial (CMF) Surgery Indicated for Orthognathic Surgery', 'orgStudyIdInfo': {'id': '2001-S-CMF-SUR MESURE-R'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Orthognatic surgery', 'description': 'Orthognathic surgery patients, adults or minors whose bone maturity is sufficient according to the investigator.', 'interventionNames': ['Device: Custom-made guides and plates']}], 'interventions': [{'name': 'Custom-made guides and plates', 'type': 'DEVICE', 'description': 'Patients will be included in the study and then followed clinically according to the routine care of orthognathic surgery with custom-made guides and plates. The only specific act this study is the completion of an OQLQ quality of life questionnaire by patients preoperatively and between 8 to 12 months postoperatively.', 'armGroupLabels': ['Orthognatic surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7500', 'city': 'Tournai', 'country': 'Belgium', 'facility': 'Cabinet chirurgie Maxillo-faciale', 'geoPoint': {'lat': 50.60715, 'lon': 3.38932}}, {'zip': '69005', 'city': 'Lyon', 'country': 'France', 'facility': 'Cabinet Orhognatic', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '42100', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Hôpital de la Loire', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '69655', 'city': 'Villefranche-sur-Saône', 'country': 'France', 'facility': 'Hôpital Villefranche sur Sâone', 'geoPoint': {'lat': 45.98967, 'lon': 4.71961}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Global D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}