Non-Contact Intraoperative Optical Imaging During Instrumentation Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pilot hole and screw trajectory accuracy as compared between post-operative CT and intraoperative images
研究概览
简要总结
For a significant number of patients suffering from back pain, even basic daily activities become impossible. It is at this time that spinal surgery becomes necessary in order to improve the patient's quality of life. To combat these symptoms, surgical implants (e.g. pedicle screws, rods, etc.) are used to aid in stabilizing and correcting the deformities of the spine, particularly after spinal decompression. Surgical navigation has a great potential to improve the accuracy of correctly implanting these devices; however, present technologies rely on intraoperative imaging that uses ionizing radiation (e.g. computed tomography, fluoroscopy, etc.), require cumbersome set-ups, the physical attachment of fiducial markers, and cannot account for patient motion. Therefore, the investigators propose a real-time intraoperative optical topographical imaging based surgical guidance system capable of accurately guiding the placement of implanted devices such as pedicle screws.
详细描述
The hypothesis is that optical visualization of surgically exposed bony anatomy with computerized navigation can accurately estimate subsurface anatomy and in the future, potentially guide the placement of pedicle screws during spinal surgery. The specific research aims are as follows: i) an intraoperative non-contact optical imaging system can quantify the entry point and trajectory of pedicle screws implanted by the spine surgeon; and ii) intraoperative optical imaging can predict the entry point and trajectory of pedicle screws as verified by post-operative computed tomography (CT) scans.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than 18 years of age
- •Able to provide consent, or have substitute decision maker available FOR SPINAL INDICATIONS
- •Scheduled to undergo spinal instrumentation surgery involving pedicle screw insertion
- •Scheduled for pre-operative CT scan and the surgical plan includes open exposure of the posterior bony elements of one or more level(s) of the vertebra(e)
- •No contra-indication for a post-operative CT scan FOR CRANIAL INDICATIONS
- •scheduled to undergo cranial surgery
- •Scheduled for pre-operative CT or MRI scan
- •No contra-indication for post-operative CT scan
排除标准
- •Previous spinal decompression with significant laminectomy performed at the level intended for instrumentation
- •Previous spinal decompression with laminoplasty performed at the level intended for instrumentation
研究组 & 干预措施
BBL Experimental Navigation System
As this is a single arm trial, all participants receive treatment.
干预措施: BBL Experimental Navigation System (Device)
结局指标
主要结局
Pilot hole and screw trajectory accuracy as compared between post-operative CT and intraoperative images
时间窗: Within 1 week of screw placement
Comparison and quantification of accuracy of pilot holes including entry point and trajectory as taken from experimental navigation system as compared to absolute (or actual) entry point and trajectory of screws as determined by post-operative computed tomography scans.
次要结局
未报告次要终点
研究者
Dr. Victor Yang
Senior Scientist, Physical Sciences Platform
Sunnybrook Health Sciences Centre