Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System f… (NCT05565131) | Clinical Trial Compass
CompletedNot Applicable
Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery
France14 participantsStarted 2022-09-23
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 :
* Traumatology: fracture with significant vertebral compression or major kyphosis deformity, ligament and/or disc injury resulting in instability, with the need to free the marrow or nerve roots, OR
* Deformity: idiopathic scoliosis with surgical indication for increased curvature, thoracic curvature greater than 45° or lumbar curvature greater than 35°, OR
* Revision surgery for extension of the assembly in the presence of a possible adjacent syndrome responsible for instability and/or central or foraminal stenosis, OR
* Degenerative: symptomatic spondylolisthesis, degenerative scoliotic deformity, narrow lumbar canal with canal release leading to instability, syndrome adjacent to a previously performed montage.
* 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:
* Patients with contraindication to screw placement
* Patients with contraindication to CT scan
* Silicon allergy
* The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
* The patient is unable to express their consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state gu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Accuracy of the PYTHEAS® ODYSSEE angular assistance device for directing the pedicle