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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
14
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.
Hôpital Saint Joseph
Marseille, France
CHU de Nimes
Nîmes, France
Accuracy of the PYTHEAS® ODYSSEE angular assistance device for directing the pedicle
Number of perforations with the correct direction/Total number of perforations performed. The correct direction will be determined using a palpator guide before screw placement, and considered satisfactory when the internal, external, superior and inferior walls of the intra-pedicular path are respected
Time frame: Day 0
Correct screw positioning rate
Number of correctly positioned screws (in trans-pedicular) / Number of screws placed. Correct placement determined by CT scan performed immediately postoperatively
Time frame: Day 0
Adverse events
No adverse events are anticipated directly linked to the device
Time frame: Day 0
Operating time according to the calibration mode performed (specific mode/global mode)
Operating time (minutes): time from incision until closing indicated on the management software.
Time frame: Day 0
Surgeon's satisfaction with the calibration (specific/global)
5-level Likert scale + one item with open-ended. The questions asked will be: * Are you satisfied with the specific calibration? * Are you satisfied with the overall calibration? * What type of calibration would you prefer to use in practice? In which cases?
Time frame: Day 0
Surgeon's satisfaction with technical quality of the transfer between the PYTHEAS tablet and the computer for each procedure
5-level Likert scale + one item with open-ended. The questions asked will be: * Are you satisfied with the transfer time between the tablet and the computer? * Are you satisfied with the ease of transfer between the tablet and the computer?
Time frame: Day 0
Surgeon's satisfaction with tablet interaction
5-level Likert scale + suggestions for improvement. The questions asked will be: * Are you satisfied with the responsiveness of the tablet? * Are you satisfied with the interactivity of the tablet? * Are you satisfied with the quality of the images displayed by the tablet? * Suggestions for improvement.
Time frame: Day 0
Surgeon's reported overall usability of the PYTHEAS® ODYSSEE
The System Usability Scale (SUS): a 10-item questionnaire where a score of 75 or more is generally considered "good", and 50 to 75 is considered "fair" or "adequate". A score below 50 indicates major problems in terms of satisfaction.
Time frame: Day 0
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