Randomized Controlled Trial of DuraGen Plus® Adhesion Barrier Matrix to Minimize Adhesions Following Lumbar Discectomy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 347
- 试验地点
- 36
- 主要终点
- Radiological, Pain, and Functional Outcome Assessments
研究概览
简要总结
To evaluate the safety and effectiveness of DuraGen Plus® Adhesion Barrier Matrix as an adhesion barrier in spinal surgery to reduce the extent of peridural fibrosis formation and radicular pain in comparison to a control group receiving standard care.
详细描述
For more information, please visit www.DuragenStudy.com
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(Abstracted from clinical protocol):
- •Patients with radicular pain requiring single-level, lumbar hemi-laminectomy or hemilaminotomy procedures with discectomy in the lower lumbar spine
- •Require initial open lumbar surgery for extruded, prolapsed or bulging intervertebral discs
- •Requires removal of herniated disc fragment
排除标准
- •(Abstracted from clinical protocol):
- •Current or historic open traumatic injury to the spine
- •Any previous surgery to the lumbar spine or percutaneous tissue destruction or ablation procedures
- •Women who are nursing, women who are pregnant and women who are planning to become pregnant during the time of the study
- •Any spinal conditions or systemic diseases that would preclude the patient from participation in the clinical trial
- •Clinically significant structural disorders
- •Known positive for HIV
- •Insulin-dependent Diabetes Mellitus patients
- •Morbid obesity (Body Mass Index greater than or equal to 40 kg/m2)
- •History of alcohol or drug abuse within 2 years prior to randomization
研究组 & 干预措施
1
Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
干预措施: DuraGen Plus Adhesion Barrier Matrix (Device)
2
Control arm is surgery alone (no adhesion barrier)
结局指标
主要结局
Radiological, Pain, and Functional Outcome Assessments
时间窗: 6 months
Radiological score (MRI Outcome score): MRI peridural fibrosis in 5 consecutive 2-D axial Spin Echo T1 axial slices. Score consists of the ratio of total available space in each image and the amount of scar identified (percentage). Pain (VAS): Visual Analog Score used to rate the subject's pain.VAS scale is a 100 mm horizontal line, where the far left side of the scale equals (0) no pain and the far right side of the scale (100) equals the worst possible pain. Functional outcome score (ODI): Used to assess the effect leg or back pain on everyday life. Questions relate to areas such as walking, lifting, sitting, ability to travel as well as other common activities. Ten questions with scores from 0-5. Calculated as percentage: (Actual score /Maximum overall score (worst disability))\*100.
次要结局
- Radiological, Pain, and Functional Outcome Assessments(12 months)