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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Accuracy of the PYTHEAS® ODYSSEE angular assistance device for directing the pedicle
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
PAtients requiring pedicle screw implantation
干预措施: Guided placement with PYTHEAS® ODYSSEE (Device)
结局指标
主要结局
Accuracy of the PYTHEAS® ODYSSEE angular assistance device for directing the pedicle
时间窗: 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
次要结局
- Adverse events(Day 0)
- Operating time according to the calibration mode performed (specific mode/global mode)(Day 0)
- Surgeon's satisfaction with technical quality of the transfer between the PYTHEAS tablet and the computer for each procedure(Day 0)
- Surgeon's satisfaction with tablet interaction(Day 0)
- Correct screw positioning rate(Day 0)
- Surgeon's satisfaction with the calibration (specific/global)(Day 0)
- Surgeon's reported overall usability of the PYTHEAS® ODYSSEE(Day 0)