Stabilimax Study Participants Collection of Additional Follow-up Data Clinical Investigation Plan R-001
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS) for Leg Pain
研究概览
简要总结
The intent of this study is to complete the collection of clinical data on subjects enrolled in the Stabilimax Dynamic Spine Stabilization IDE clinical trial (#G060214) sponsored by the now defunct Applied Spine Technologies Inc . The Applied Spine assets, including the clinical trial data, were acquired by Rachiotek, LLC in 2010. When Applied Spine ceased their funding of the trial, a number of enrolled patients had not yet completed the two year follow-up visit defined as the study endpoint in the clinical investigation plan. No additional patient treatment is required to complete the study. Rachiotek has interest in pursuing IDE approval for a new study and the information collected in this study is essential for supporting the new Investigational Device Exemption application.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient that after having met all of the inclusion/exclusion criteria identified for the Stabilimax Investigational Device Exemption study had enrolled in the Stabilimax Investigational Device Exemption study and were implanted with the Stabilimax NZ or the control device.
排除标准
- •Any patient that has had the device removed and the adverse event follow-up report stated that the event was resolved. This applies only if the patient was formally withdrawn from the study at that time.
结局指标
主要结局
Visual Analog Scale (VAS) for Leg Pain
时间窗: Minimum 24 months post procedure
Patient demonstrates a reduction in leg pain from baseline of at least 20 mm on a 100 mm visual analog scale (VAS)
Revision, Reoperation, or Removal
时间窗: Minimum 24 months post procedure
The treated level did not require surgical revision, reoperation, removal, or supplemental fixation.
Zurich Claudication Questionnaire (ZCQ)
时间窗: Minimum 24 months post procedure
Clinically significant improvement from baseline defined by a minimum decrease of .5 as measured by the Zurich Claudication Questionnaire for both Symptom Severity(SS) and Physical Function (PF) scores
Major Device Related (MDR) Complications
时间窗: Minimum 24 months post procedure
Patient experiences no major device-related complications
次要结局
- Presence (control) or Absence (Stabilimax)of fusion(Minimum 24 months post procedure)
- Physician Satisfaction Scale(Immediately post procedure)
- Oswestry Disability Index (ODI)(Minimum 24 months post procedure)
- Adverse Events (AE)(Minimum 24 months post procedure)