Feasibility Study of Pedicle Screw Placement in the Spine With the XVISION SPINE System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 5
- 主要终点
- accurate placement of pedicle screws
研究概览
简要总结
Open label, prospective, single arm, multi-center study. Pedicle screws placement in sacral/lumbar vertebrae will be performed via open procedural technique, by at least two (2) different surgeons, using the XVISION SPINE system.
Pedicle screw placement accuracy will be assessed by two independent, experienced radiologists, using the Gertzbein score.
Subjects will undergo intraoperative 3D scan prior to screws placement to enable 3D model rendering and XVISION SPINE system registration.
Subjects will undergo intraoperative 3D scan post procedure to enable offline scoring of pedicle screw placement using the Gertzbein score.
Surgeons performing the procedures will be requested to fill in usability questionnaires at the end of the procedure
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 18 - 80 yrs.
- •Subjects with Spondylosis scheduled to undergo an elective short (6 or less consecutive vertebrae) S1-L1 open spinal fixation surgery using pedicle screws.
- •Subjects requiring a posterior approach surgical procedure.
- •Subjects with normal global spinal alignment (coronal, sagittal view) and/ or patients with degenerative spine disorders.
排除标准
- •Subjects with severe Osteoporosis (T score <-3.5)
- •Subjects with kyphosis at the operated area (≥ stage 3)
- •Subjects with Spondylolisthesis Grade III and above.
- •Subjects scheduled for revision fusion surgery (prior laminectomy or discectomy is not excluded).
- •Subjects with significant abnormalities of bones (e.g. osteogenesis imperfecta, tumors, infection or malignancy, etc.)
- •Subjects with neurologic diseases or damage (e.g. due to trauma, tumor, Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, spina bifida or neurofibroma)
- •Subjects with spinal cord abnormalities with any neurologic symptoms or signs
- •Paraplegia.
- •Pedicle fracture documented before or during surgery.
- •Women pregnant or lactating
- •Subjects requiring anterior release or instrumentation.
- •Subjects who are unwilling to sign written informed consent and assent to participate in the study.
结局指标
主要结局
accurate placement of pedicle screws
时间窗: through study completion , an average of 6 months.
accurate placement will be evaluated using Gertzbein and Robbins
次要结局
- usability and ease of use of the system: questionnaire(The surgeon fills a questionnaire after the surgery, within 7 days.)