A Study to Evaluate the Safety and Effectiveness of the TOPS™ SP System
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Pain Improvement
研究概览
简要总结
The TOPS™ SP System is intended to provide stabilization in skeletally mature patients. The system is designed to afford motion of the spine segment without fusion. The pur0pose of this prospective clinical study is to establish the safety and effectiveness of the TOPS™ System, when used following decompression, in the treatment of lower back and sciatic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic monosegmental lumbar spinal stenosis or facet arthrosis
- •Patients with degenerative spondylolisthesis
- •Patients with at least 3 months failed conservative treatment
- •Narrowing of the lumbar spinal canal
- •Patients with lower back pain or sciatica
排除标准
- •Discogenic back pain at TOPS System level
- •Back or non-radicular leg pain of unknown etiology at TOPS System level
- •Lytic spondylolisthesis at TOPS System level
- •More than one motion segment involved in degenerative pathology to the extent that justifies its inclusion in the surgical procedure
- •Known allergy to titanium and/or polyurethane
研究组 & 干预措施
Lower Back and Leg Pain Patients
Patients suffering from lower back and leg pain resulting in degenerative spondylolisthesis and/or spinal stenosis will undergo treatment using the TOPS™ System
干预措施: TOPS™ System (Device)
结局指标
主要结局
Pain Improvement
时间窗: 24 months
Subjects having a 15% reduction in the Oswestry Low Back Pain Disability Questionnaire score as compared to their preoperative Oswestry score
Function Improvement
时间窗: 24 months
Subjects having a 15% reduction in the Oswestry Low Back Pain Disability Questionnaire score as compared to their preoperative Oswestry score
Fusion Prevention
时间窗: 24 months
The subjects will be considered a failure if fusion occurs as defined in the radiographic protocol
次要结局
未报告次要终点