NCT05565131

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Pedicle screw malposition is a common problem for spine surgeons. A poorly placed screw can lead to potentially serious complications (hemorrhage, paralysis) in the short- or medium-term. Accurate images during surgery facilitates preoperative planning and aids the placement of pedicle screws. Surgical navigation covers all techniques and equipment (hardware and software) needed to perform a computer-assisted procedure with 3D image visualization of the surgical act. Surgical navigation systems have been on the market for about 15 years. Surgical navigation increases the accuracy of pedicle screw placement. Many technologies are available, but they are expensive and often require extensive instrumentation. The PYTHEAS® ODYSSEE angular assistance system has many advantages over more widely used systems. Indeed, this system provides surgeons with the necessary information to correctly insert pedicle screws during posterior spondylodesis procedures for the treatment of deformity, osteoarthritis (degenerative spine) and trauma. Compared to competing solutions, the purpose of this device is to reduce pedicle screw malpositioning while offering minimal radiation exposure and the least possible impact on the conventional surgical workflow. It is a lightweight, efficient and easy-to-use medical device with 2-step functionality: 1) Surgical planning of pedicle screws based on a preoperative scan; 2) Angular assistance tool during surgery. The study investigators wish to evaluate the performance and safety of the PYTHEAS® ODYSSEE medical device (not CE marked) as well as its usability in a pilot study of first use in humans. Without a navigation system, the literature reports that on average 9 to 10% of perforations are incorrectly positioned by the "free hand" method. With the PYTHEAS® ODYSSEE angular assistance device, the study hypothesis is that this rate will be 5%, i.e. a 50% improvement.

Conditions

• Pedicle Screw
• Surgical Navigation Systems

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-23
• Primary completion: 2023-03-14
• Completion: 2023-03-14
• First posted: 2022-10-04
• Last updated: 2023-04-05

Locations

2 sites across 1 country: France