Pedicle ScrewODYSSEENCT05565131
Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery
A study testing Guided placement with PYTHEAS® ODYSSEE in people with Pedicle Screw and Surgical Navigation Systems, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pedicle Screw, Surgical Navigation Systems
- What is being tested?
- Guided placement with PYTHEAS® ODYSSEE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesFrance
- Study dates
- 23 Sep 2022to 14 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 guardianship
- Pregnant, parturient or breastfeeding
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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
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.
Read more
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
- Being tested
- Guided placement with PYTHEAS® ODYSSEE
- Keywords
- Spinal deformity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided placement with PYTHEAS® ODYSSEEDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| PAtients requiring pedicle screw implantation | Experimental | Not described Receives: Device: Guided placement with PYTHEAS® ODYSSEE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0
Secondary outcomes (7)
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
Measured: Day 0
Adverse events
No adverse events are anticipated directly linked to the device
Measured: 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.
Measured: 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?
Measured: 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?
Measured: 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.
Measured: 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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start23 Sep 2022
- Primary completion14 Mar 2023
- Study completion14 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pedicle ScrewStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Haignere, Principal investigator, CHU de Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565131
- Sponsor's protocol ID
- IDIL/2021/VH-01
- Acronym
- ODYSSEE
- Status last verified
- Sep 2022
- First submitted
- 27 Sep 2022
- Last updated
- 21 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41963965
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05565131
- Acronym / sponsor ID
- ODYSSEE / IDIL/2021/VH-01
- Conditions
- Pedicle Screw, Surgical Navigation Systems
- Keywords
- Spinal deformity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 14 Mar 2023 (actual)
- Study completion
- 14 Mar 2023 (actual)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAtients requiring pedicle screw implantation | Experimental | Device: Guided placement with PYTHEAS® ODYSSEE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided placement with PYTHEAS® ODYSSEEPre-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. | Device | PAtients requiring pedicle screw implantation |
Primary outcome
Accuracy of the PYTHEAS® ODYSSEE angular assistance device for directing the pedicle
Time frame: Day 0
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
7 secondary outcomes
Correct screw positioning rate
Time frame: Day 0
Adverse events
Time frame: Day 0
Operating time according to the calibration mode performed (specific mode/global mode)
Time frame: Day 0
Surgeon's satisfaction with the calibration (specific/global)
Time frame: Day 0
Surgeon's satisfaction with technical quality of the transfer between the PYTHEAS tablet and the computer for each procedure
Time frame: Day 0
Surgeon's satisfaction with tablet interaction
Time frame: Day 0
Surgeon's reported overall usability of the PYTHEAS® ODYSSEE
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Results publication: PubMed 41963965Haignere 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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SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion
Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis
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Retrospective Evaluation of Upper Instrumented Vertebrae (UIV) Screw Loosening Following Spine Surgery
Thoracolumbar Spinal Fusion
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Analysis of Sub Axial Cervical Pedicle Spine Based on CT
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Haignere principal investigator
CHU de Nimes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided placement with PYTHEAS® ODYSSEE in people with Pedicle Screw and Surgical Navigation Systems, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the PYTHEAS® ODYSSEE angular assistance device for directing the pedicle (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05565131, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.