Prospective Study to Evaluate the Performance and Safety of Custom-made Implants in Cranio-Maxillofacial (CMF) Surgery Indicated for Orthognathic Surgery

CompletedOBSERVATIONAL
Enrollment

56

Participants

Timeline

Start Date

September 17, 2021

Primary Completion Date

February 25, 2025

Study Completion Date

February 25, 2025

Conditions
SurgeryOrthognathic SurgeryOrthognathic Surgical Procedures
Interventions
DEVICE

Custom-made guides and plates

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.

Trial Locations (4)

7500

Cabinet chirurgie Maxillo-faciale, Tournai

42100

Hôpital de la Loire, Saint-Etienne

69005

Cabinet Orhognatic, Lyon

69655

Hôpital Villefranche sur Sâone, Villefranche-sur-Saône

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Global D

INDUSTRY