A Prospective, Multicenter, Single-group, Target-value Clinical Trial to Evaluate the Safety and Efficacy of Single-use Annular Sutures for Annular Incisions Following Nucleus Pulposus Removal
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 135
- 主要终点
- Success rate of suture
研究概览
简要总结
The objective of this clinical trial was to evaluate the safety and effectiveness of single-use annular sutures for the closure of annular incisions after nucleus pulposus removal. Participants used single-use annular sutures to close the annular fibers. The success rate of suture, reduction value of annulus, proportion of annulus reduction, intraoperative blood loss, suture time, VAS pain score (low back, bilateral lower extremities), Oswestry index (ODI index), and Short were evaluated The effectiveness evaluation results of Form-12 health survey (SF-12 score), treatment success rate, device defects, product operation satisfaction, and safety evaluation results of recurrence rate, adverse events, and serious adverse events were used to verify the safety and effectiveness of disposable fibrillar suture for annular incision suture after nucleus pulposus removal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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, gender unlimited;
- •Meet the diagnosis of lumbar disc herniation (refer to the Guidelines for Diagnosis and Treatment of Lumbar disc herniation), and expect to undergo single-level disc nucleus pulposus extraction;
- •The history of lumbar disc herniation is more than 6 weeks, and systematic conservative treatment is ineffective；
- •ODI index ≥20 points;
- •In the VAS score of bilateral lower limbs, at least one side was ≥4 points;
- •The score of the three evaluation indicators according to the modified Pfirrmann grade, age and disc height is no more than 7 points (see Annex 1 for the criteria);
- •Voluntarily participate and sign informed consent;
- •Be able to communicate well with research doctors, have good compliance, and can follow the requirements of clinical research.
排除标准
- •Laboratory examination (blood routine examination, blood biochemistry, coagulation function and blood pregnancy, etc.), imaging examination (MRI) and vital signs examination have abnormal results with clinical significance, and the researchers believe that they are not suitable for inclusion;
- •Active local or systemic infection;
- •Patients with lumbar tumors and/or spinal malformations;
- •Imaging showed calcification of the posterior longitudinal ligament;
- •A history of serious diseases of important organs (such as cardiovascular system, liver, lung, kidney and nervous system);
- •There are autoimmune diseases or abnormal coagulation function;
- •Previous or planned surgical procedures to fuse or stabilize the lumbar spine during the trial;
- •Intraoperative exploration of the location of the annulus fibriatus could not satisfy the requirement that the needle entry point was more than 2mm away from the margin of the annulus fibriatus;
- •Pregnant or lactating women, or those who have a pregnancy plan during the trial period;
- •Those who are participating in other clinical trials at the same time;
- •Other situations that the researcher considers inappropriate to participate in this study.
结局指标
主要结局
Success rate of suture
时间窗: Immediately after surgery
After the intraoperative suture was completed, the quality of the suture was evaluated by the investigator. After all subjects completed the operation, the success rate of suture was calculated. Evaluation criteria: 1) No sutures fell off during the suture process; 2) No suture fracture during the suture process; 3) A sterile scale was used to measure annulus fibrosus cleft before and after suture, and medical image data were retained. Finally, the size changes of cleft before and after suture were compared. The size of the wound after suture should be reduced by more than 60% compared with that before suture (the size of the annulus fibrous tear should be determined by its maximum diameter). If all the above three conditions are met, the suture is successful. If any one of the conditions is not met, the suture is failed. Successful rate of suture = Number of successful sutures/total number of sutures \*100%
次要结局
- Intraoperative blood loss(The day after the surgery)
- Annulus fibril cleft decreased in value(During the surgery.)
- SF-12 rating(Before surgery, 4 days after surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery)
- VAS pain score (lower back, bilateral lower limbs)(Before surgery, 4 days after surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery)
- Suture time(The day after the surgery)
- Reduced proportion of annular fibril cleft(During the surgery.)
- Treatment success rate(Six months after surgery)
- ODI index(Before surgery, 4 days after surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery)