NCT02108249已完成不适用
Annex™ Adjacent Level System for Treatment of Adjacent Level Disease
Spine Wave1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2014年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Surgical Complication rate compared to retrospective chart review
研究概览
简要总结
The purpose of this study is to evaluate the clinical, radiological, and surgical outcomes of the Annex™ Adjacent Level System for the treatment of adjacent level disease of the lumbar spine. The Annex™ Adjacent Level System is a spinal fixation system intended to be used with commercially available pedicle screw fixation systems in order to extend existing pedicle screw constructs. Subjects will be evaluated over a 2 year period and compared to historical control.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women 18-85 years of age
- •Single level adjacent level segment disease (ALD) in the lumbar spine (L1-S1).
排除标准
- •trauma, tumor, pseudoarthrosis, revision, or same-level recurrent stenosis
- •cervical fusion candidates
- •extraspinal cause of back pain
- •local or systemic infection
- •pregnant / able to become pregnant and not following a reliable contraceptive method
- •Severe osteoporosis or osteopenia
- •Morbid obesity defined as BMI > 40
- •Anatomy or other factors that prohibit safe surgical access to the surgical site
- •Allergy or sensitivity to any component of the treatment procedure
- •Inadequate tissue coverage over the operative site
- •Inadequate bone stock or bone quality
- •Fever or leukocytosis
- •Uncorrectable coagulopathy or hemorrhagic diathesis
- •Cardiopulmonary conditions that present prohibitive anesthesia risk
- •Neuromuscular disease or disorder
- •Mental illness
- •Has an active workman's compensation claim
结局指标
主要结局
Surgical Complication rate compared to retrospective chart review
时间窗: Within 30 days of treatment
% Improvement in Operative/Discharge parameters including surgical time and hospital stay
时间窗: within 30 days after treatment
次要结局
- % Improvement in Quality of Life using SF-36(Up to 2 years post-treatment)
- % Patient Satisfaction with procedure(Up to 2 years post-treatment)
- % Improvement in Disability using ODI(Up to 2 years post-treatment)
- % Pain reduction on VAS(Up to 2 years post-treatment)
研究者
研究点 (1)
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