Evaluation of the Performance and Safety of Plenum® Tissue Ortho for the Prevention of Epidural Fibrosis and Post-laminectomy Syndrome After Microdiscectomy, for the Treatment of Disc Herniation
试验速览
- 阶段
- 不适用
- 发起方
- M3 Health
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Patient's quality of life
研究概览
简要总结
The goal of this clinical trial is to compare if adding a polydioxanone membrane prevents epidural fibrosis and, consequently, the rate of occurrence of the post-laminectomy syndrome in participants undergoing microdiscectomy for treatment of disc herniation.
详细描述
Participants will be submitted to microdiscectomy with the addition of a polydioxanone membrane over the dura mater in the test group and without in the control group.
The groups will be compared regarding improving patients' quality of life, evaluation of epidural fibrosis, and device safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pain radiating to one of the legs confirmed with an MRI scan;
- •Patients who have already undergone conservative treatment (treatment with medication and physiotherapy) for at least 6 weeks, but have not shown improvement;
- •Non-pregnant women or women of childbearing age who use contraceptive methods;
- •Having signed the free and informed consent form (TCLE).
排除标准
- •Patients with concomitant pathologies (eg infection or tumor and segmental instability or vertebral fractures);
- •Cauda equina syndrome;
- •Strength deficit characterized by strength equal to or less than III/V;
- •Previous surgery of the lumbar spine;
- •Patientes who have wound healing disorders;
- •Patients with contraindications for evaluating MRI with the use of contrast;
- •More than 1 herniated disk.
研究组 & 干预措施
Polydioxanone membrane
After flavectomy and manipulation of the spinal nerve and dura mater to resect the herniated intervertebral disk, the membrane will be placed on top of the dura mater.
干预措施: Plenum® Tissue ortho membrane (polydioxanone membrane) (Device)
Control
The microdiscectomy procedure will be performed routinely, without the addition of any device over the dura mater.
结局指标
主要结局
Patient's quality of life
时间窗: Change from the baseline, to immediate potostoperative period (14 days) and to late postoperative period (6 months).
Assessed by the Oswestry Questionnaire for lumbar evaluation (The low back pain disability Oswestry questionnaire).
次要结局
- Patient's quality of life(Before the procedure, in the immediate postoperative period (14 days) and in the late postoperative period (6 months).)
- Intervention safety(Through study completion, an average of 6 months)
- Epidural fibrosis(6 months postoperatively.)
- Low back and leg pain(Before the procedure, in the immediate postoperative period (14 days) and in the late postoperative period (6 months).)