A Controlled Clinical Study on the Safety and Effectiveness of Barb Suture in Obese Patients Undergoing Posterior Cervical Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- NDI score change
研究概览
简要总结
Through a single-center, exploratory clinical study, the safety and effectiveness of using barb wire in the incision and suture of posterior cervical surgery in obese patients were evaluated, providing a basis for its wide clinical application in posterior cervical surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 28 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptoms and signs of the patients were typical. MRI showed single or multiple central herniation of C3-C7 intervertebral discs or spinal stenosis at corresponding levels, which confirmed cervical myeloid cervical spondylosis or cervical spinal stenosis.
- •Preoperative routine tests and examinations showed no contraindications.
- •Informed consent was obtained from the patient and his family, informed consent was signed, and a complete follow-up was completed after surgery.
排除标准
- •A history of wasting diseases associated with malignancy and chemoradiotherapy that may interfere with wound healing
- •History of dermatosis
- •History of immune system diseases
- •History of blood diseases
- •Skin injury or defect at the back of the neck
- •Severe hypersensitivity
- •Cold, fever, trauma or other infections in the week before surgery
- •Infectious disease
- •Psychosis could not cooperate with follow-up
研究组 & 干预措施
postoperative (4 weeks)
干预措施: posterior cervical surgery (Procedure)
postoperative (3 months)
干预措施: posterior cervical surgery (Procedure)
Preoperative
postoperative (2 weeks)
干预措施: posterior cervical surgery (Procedure)
结局指标
主要结局
NDI score change
时间窗: 3 months after surgery
NDI score is used to assess the disorder of spinal cord which is in the form of questionnaires. Postoperative improvement rate = (total score)/ (numbers of programme X5) X100%. Improvement rate can also correspond to the commonly used efficacy criteria: the improvement rate when 60%-80% means extremely severe dysfunction, when 40%-60% means severe dysfunction, when 20-40% means moderate dysfunction, and when less than 20% means mild dysfunction.
VAS score change
时间窗: 3 months after surgery
A Visual Analogue Scale (VAS) is used to measure the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. Using a ruler, the score is determined by measuring the distance (mm) on the 10cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
JOA score change
时间窗: 3 months after surgery
JOA score is used to assess the function of spinal cord which is in the form of questionnaires. Postoperative improvement rate = ((postoperative score - preoperative score)/ (17- preoperative score)) X100%. Improvement rate can also correspond to the commonly used efficacy criteria: cure when the improvement rate is 100%, effective when the improvement rate is greater than 60%, effective when 25-60%, and ineffective when less than 25%.
次要结局
- wound infection(2 weeks after surgery, 4 weeks after surgery, 3 months after surgery)
- wound dehiscence(2 weeks after surgery, 4 weeks after surgery, 3 months after surgery)