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

NCT05565131 | Completed

• 1 other identifier: IDIL/2021/VH-01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Spinal deformity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Correct screw positioning rate

  Day 0

• Adverse events

  Day 0

• Operating time according to the calibration mode performed (specific mode/global mode)

  Day 0

• Surgeon's satisfaction with the calibration (specific/global)

  Day 0

• Surgeon's satisfaction with technical quality of the transfer between the PYTHEAS tablet and the computer for each procedure

  Day 0

Study Arms (1)

PAtients requiring pedicle screw implantation

EXPERIMENTAL

Device: Guided placement with PYTHEAS® ODYSSEE

Interventions

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.

PAtients requiring pedicle screw implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with contraindication to screw placement
• Patients with contraindication to CT scan
• Silicon allergy
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

Hôpital Saint Joseph

Marseille, France

Location

CHU de Nimes

Nîmes, France

Location

Related Publications (1)

• 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. doi: 10.1186/s13018-026-06749-9. Online ahead of print.

  PMID: 41963965 RESULT

Study Officials

• Vincent Haignere

  CHU de Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 4, 2022
• Study Start: September 23, 2022
• Primary Completion: March 14, 2023
• Study Completion: March 14, 2023
• Last Updated: April 21, 2026

Record last verified: 2022-09

Locations

FR (2)