A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 166
- 试验地点
- 23
- 主要终点
- Rate of success at the 24-month follow-up visit
研究概览
简要总结
To compile real-world outcomes of the Superion™ IDS in routine clinical practice.
详细描述
To compile real-world outcomes of the Superion™ IDS in routine clinical practice, when used according to the applicable Directions for Use
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •45 years of age or older when written informed consent is obtained
- •Persistent leg/buttock/groin pain, with or without back pain that is consistently relieved by flexion activities (example: sitting or bending over a shopping cart).
- •Diagnosis of degenerative spinal stenosis of the lumbar spine, defined as the narrowing of the midline sagittal spinal canal (central) and/or narrowing between the facet superior articulating process (SAP), the posterior vertebral margin (lateral access), and the nerve root canal (foraminal).
- •Subject signed a valid, IRB-approved informed consent form (ICF) provided in English.
- •Subjects, who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, cooperate with the investigational procedures and are willing to return for all the required post-treatment follow-ups.
- •Able to independently read and complete all questionnaires and assessments provided in English
排除标准
- •Axial back pain only.
- •Fixed motor deficit in lower extremity(ies) due to LSS.
- •Has any pain-related diagnosis, medical/psychological condition or external factors that, in the investigator's medical judgment, might confound reporting of study outcomes (e.g. history of pelvic pain, anginal pain, chronic migraine, involved in litigation, workmen's compensation, spinal tumor)
- •Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study
研究组 & 干预措施
Superion™ IDS device
Superion™ Indirect Decompression System (IDS)
干预措施: Superion™ IDS device (Device)
结局指标
主要结局
Rate of success at the 24-month follow-up visit
时间窗: 24-Months
Non-inferiority of overall subject success at the 24-Month visit vs. the 24-month visit in IDE trial. An individual subject will be considered a success if they meet all of the following conditions at the 24-month follow-up visit: 1. Clinically significant improvement of neurogenic claudication symptoms as determined by meeting at least two of three domains of the ZCQ * ≥ 0.5-point improvement in physical function * ≥ 0.5-point improvement in symptom severity * ≤ 2.5 point on patient satisfaction domain 2. No reoperations, removals, revisions, or supplemental fixation at the index level(s) 3. No major implant or procedure-related complications * no dislodgement, migration, or device deformation * no new or persistent worsened neurological deficit at the index level† * no unhealed spinous process fractures † Defined as a serious adverse event wherein there is any new/worsening of motor or sensory function at 12 months, compared to baseline, which persists to 24 months
次要结局
- Patient Satisfaction: VertiFlex® Patient Satisfaction Survey(24-, 36-, 48- and 60-Months)