A Multicentric Retrospective Evaluation of Clinical and Radiologic Outcome of All Patients Treated With a Removable Percutaneous Interspinous Process Spacer (LobsterProject® Techlamed®) for Symptomatic Degenerative Lumbar Spinal Stenosis in 2019.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Oswestry Disability Index
研究概览
简要总结
Purpose To evaluate clinical and radiologic outcome of a series of patients treated with a removable percutaneous interspinous process spacer (IPS) (LobsterProject® Techlamed®) for symptomatic degenerative lumbar spinal stenosis (DLSS).
Methods All patients treated in the two considered Centres with this IPS during 2019 were retrospectively reviewed. Patients with incomplete clinical or radiological documentation were not included. Procedures were performed under deep sedation or general anaesthesia by two interventional radiologists. Patients were clinically evaluated before intervention and at 3-month follow-up with Visual Analog Scale for pain (VAS), Oswestry Disability Index (ODI) and radiologically with MRI or CT scans. Neural foramina were independently measured for each patient on pre- and post-procedural CT scans by two radiologists.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •removable percutaneous IPS treatment
- •attended interventional radiology outpatient consultations for back pain and NIC, refractory to medical treatment
排除标准
- •PS positioning included cauda equina syndrome
- •permanent motor deficit,
- •previous spine surgery,
- •spondylolisthesis greater than Meyerding grade I,
- •local or systemic infection and severe osteoarthritis with pronounced osteophytosis or bone bridges
结局指标
主要结局
Oswestry Disability Index
时间窗: 3 Months
Disability level evaluated with Oswestry Disability Index after intervention
次要结局
- Visual Analog Scale for pain(3 Months)
- Variation of foraminal area(3 Months)