Efficiency of 3D-printed Implant Versus Autograft for Orbital Reconstruction (TOR-3D)

NARecruitingINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

May 4, 2023

Primary Completion Date

February 28, 2027

Study Completion Date

February 28, 2027

Conditions
Significant Bone Defect in the Orbit
Interventions
PROCEDURE

Bone autograft

The principle of this surgery is based on the removal of a portion of the outer bone layer from the vault of the skull in order to have a flat and solid bone element (cortical bone), which can be carved freehand to better replace the defective bone wall.

PROCEDURE

Orbital reconstruction by 3D-printed porous titanium implant

"From data of a patient's CT-scan, it is possible to perform a mirroring. The unaffected orbit is mirrored onto the affected orbit, via a virtual treatment planning, in order to rely on facial symmetry to virtually restore healthy anatomy. From this simulation, the implant is 3D-printed by Selective Laser Melted (SLM) technique using titanium powder. This technique enabling the creation of custom-made implants is called computer-aided design and computer-aided manufacturing (CAD-CAM).~After sterilization, the implant is ready to be placed during a surgical procedure."

Trial Locations (1)

69495

RECRUITING

Hospices Civils de Lyon, Groupement Hospitalier Sud Chirurgie maxillo-faciale, Pierre-Bénite

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER