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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAtients requiring pedicle screw implantation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guided placement with PYTHEAS® ODYSSEE | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 0 |
| Adverse events |
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Inclusion Criteria:
Patient with indication for posterior arthrodesis of at least 2 lumbar or thoracic vertebrae with placement of pedicle screws at vertebral level for :
The patient must have given their free and informed consent and signed the consent form
The patient must be a member or beneficiary of a health insurance plan
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vincent Haignere | CHU de Nimes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Saint Joseph | Marseille | France | ||||
| CHU de Nimes |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41963965 | Result | Haignere V, Faure A, Giorgi H, Afonso D, Luquiens G, Kabani S, Chevallier T, Kouyoumdjian P. Performance and safety of the PYTHEAS Your Guided Trajectory(R) for intra-pedicular screw placement in spine surgery. J Orthop Surg Res. 2026 Apr 11;21(1):332. doi: 10.1186/s13018-026-06749-9. |
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No adverse events are anticipated directly linked to the device
| 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. | Day 0 |
| Surgeon's satisfaction with the calibration (specific/global) | 5-level Likert scale + one item with open-ended. The questions asked will be:
| 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:
| Day 0 |
| Surgeon's satisfaction with tablet interaction | 5-level Likert scale + suggestions for improvement. The questions asked will be:
| 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. | Day 0 |
| Nîmes |
| France |