Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery

NACompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

September 23, 2022

Primary Completion Date

March 14, 2023

Study Completion Date

March 14, 2023

Conditions
Pedicle ScrewSurgical Navigation Systems
Interventions
DEVICE

Guided placement with PYTHEAS® ODYSSEE

Pre-surgery, the surgeon generates a 3D model of the spine from a preoperative CT scan During the perforation and insertion of the implant, the system indicates the orientation of the pedicle path and the current orientation of the instruments (perforation tool) with the orientation sensor (inertial sensor). The system also displays the position of the entry point of the planned pedicle path on the views.

Trial Locations (2)

Unknown

Hôpital Saint Joseph, Marseille

CHU de Nimes, Nîmes

All Listed Sponsors
lead

Centre Hospitalier Universitaire de Nīmes

OTHER