Extended Follow-up of Investigational Device Exemption (IDE) Subjects Treated With the Simplify Cervical Artificial Disc
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 试验地点
- 28
- 主要终点
- Number of Participants With Clinical Composite Success, Parent IDE Study + Post Approval Study (PAS)
研究概览
简要总结
This study is intended to demonstrate the 5-year long-term safety and efficacy of the Simplify® Cervical Artificial Disc ("Simplify Disc") in subjects enrolled in the non-randomized Simplify Disc IDE study. This study was conducted under IDE G140154.
详细描述
This post approval study (PAS) is a continuation of the IDE pivotal study (G140154) as required under P200022. These data include long-term follow-up of subjects enrolled and treated under the IDE study from February 2016 to 2018 out to 60 months post-op. The control group is comprised of a historical ACDF population. Subjects were enrolled (signed consent) into the PAS on a rolling basis at either the 36 month, 48 month or 60 month visit based on their treatment date (under IDE G140154) and the date of PAS protocol approval. Data presented are compared to baseline data collected as part of the IDE study. Therefore, the start date and end dates of the PAS are not inclusive of the full 60 months of reported data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- All subjects enrolled in the Simplify Disc IDE study are considered for this long-term follow-up study.
排除标准
- •Subjects who were not implanted with the Simplify Disc during the IDE study
- •Subjects who had a secondary surgical intervention at the index level during the IDE study
- •Subjects who were withdrawn or withdrew consent to participate in the IDE study
- •Subjects who do not consent to participate in long-term follow-up post-approval study
研究组 & 干预措施
Simplify Disc
Extended follow-up of IDE Subjects treated with the Simplify Cervical Artificial Disc during IDE G140154
干预措施: Simplify Disc (Device)
Historical ACDF Control
Historical ACDF Data from similar protocol used as control.
干预措施: ACDF (Other)
结局指标
主要结局
Number of Participants With Clinical Composite Success, Parent IDE Study + Post Approval Study (PAS)
时间窗: IDE study 24 months + PAS 36 months = 60 months total
Individual success for Simplify Disc and the historical control Anterior Cervical Discectomy and Fusion (ACDF) is defined as follows: * Improvement on the Neck Disability Index (NDI) of at least 15 percentage points compared to baseline in the Simplify Disc IDE study, and * No device failures by Month 60, and * No subsequent surgical procedure at the index level (including revision, removal, reoperation, or supplemental fixation) by Month 60.
次要结局
- Percentage of Participants With No Dysphagia Handicap Index (DHI), Parent IDE Study + Post Approval Study (PAS)(IDE study 24 months + PAS 36 months = 60 months total)
- Clinical Improvement in One or More Radicular Symptoms or Myelopathy (Visual Analog Scale), Parent IDE Study + Post Approval Study (PAS)(IDE study 24 months + PAS 36 months = 60 months total)
- Percentage of Participants Reporting Overall Treatment Satisfaction of "Very Satisfied" or "Satisfied", Parent IDE Study + Post Approval Study (PAS)(IDE study 24 months + PAS 36 months = 60 months total)
- Percentage of Participants With No Adjacent Level Disc Deterioration (ALDD) Superior Level, Parent IDE Study + Post Approval Study (PAS)(IDE study 24 months + PAS 36 months = 60 months total)
- Participants With Maintenance or Improvement on 12-Item Short Form Survey (SF-12), Parent IDE Study + Post Approval Study (PAS)(IDE study 24 months + PAS 36 months = 60 months total)
- Number of Participants With Clinical Improvement in One or More Radicular Symptoms or Myelopathy (Neurological Status), Parent IDE Study + Post Approval Study (PAS)(IDE study 24 months + PAS 36 months = 60 months total)
- Participants Average Disc Height, Parent IDE Study + Post Approval Study (PAS)(IDE study 24 months + PAS 36 months = 60 months total)
- Percentage of Participants With No Adjacent Level Disc Deterioration (ALDD) Inferior Level, Parent IDE Study + Post Approval Study (PAS)(IDE study 24 months + PAS 36 months = 60 months total)
- Percentage of Participants With No Displacement or Migration of the Device, Parent IDE Study + Post Approval Study (PAS)(IDE study 24 months + PAS 36 months = 60 months total)