Application of 3D Printing Guide Plate in Endoscopic Spinal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- C-arm fluoroscopy times
研究概览
简要总结
Application of 3D printing guide plate in endoscopic spinal surgery
详细描述
This study applies 3D-printed customized guide plate in assisting the accurate puncture in endoscopic spinal surgeries, in patients with low back pain, lumbosacral radicular pain, abnormal sensation or muscle strength or reflex of lower extremity, cauda equina syndrome, etc. This technique can shorten reduce the intra-operative radiation, and do not affect the surgical outcome.
This study involved diseases such as lumbar disc herniation, lumbar spinal stenosis, radiculopathy, disc degeneration, etc. Endoscopic spinal surgeries are effective treatments for these disease. Needle Puncture is the key technology in endoscopic spinal surgeries.
In the past when there were no customized guides, the surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy or CT. If the position of the needles is not satisfactory, repeated procedure will be performed. This would lead to an increase in the duration of surgery and intra-operative radiation, which is detrimental to both the surgeon and the patient. This problem could be well solved by applying the 3D printing guide plate.
The key processes for the 3D printing guide plate procedure: the model of the spine or bone is established according to the patient's CT scan data to prepare the customized guide plate, then sterilize them for future use. The final position of needle is confirmed by C-arm fluoroscopy or CT or evoked pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age ≥18 years old;
- •Pain lasting ≥12 weeks;
- •The previous failure of conservative management such as physiotherapy, exercise therapy, or analgesic medications;
- •Pain intensity≥4 out of 10 on the numerical rating scale (NRS);
- •Availability of computed tomography/magnetic resonance imaging findings of pathology concordant with the side and level of their clinical features;
- •Agree with endoscopic spinal surgeries.
排除标准
- •Patient refusal to participate in the study;
- •Pregnant or nursing;
- •Allergies to local anesthetics, contrast dyes or steroids;
- •Significant anatomic deformity (either congenital or acquired) making it difficult to access the target as evidenced by computed tomography/magnetic resonance imaging;
- •Patients with platelet dysfunction, bleeding disorder or continuing anticoagulant treatment;
- •Systemic infection;
- •Injection site infection;
- •Unstable medical or psychiatric condition;
- •Unable to tolerate the surgeries.
结局指标
主要结局
C-arm fluoroscopy times
时间窗: Intraoperative
Numbers of using C-arm fluoroscopy
次要结局
- Numerical rating scale(Postoperative 1 day, 2 weeks, 1 month)
- Patient satisfaction(Postoperative 1 months)
- Puncture time(Intraoperative)
- Rate of Complications(Intraoperative)