NCT05467072招募中不适用
Post-Marketing Clinical Follow-up of an Annular Closure System
Intrinsic Therapeutics1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2023年9月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Symptomatic reherniation
研究概览
简要总结
The purpose of this retrospective chart review study is to collect the data that will be used to provide clinical evidence to support the post-market surveillance program.
详细描述
Retrospective chart review of patients treated with lumbar discectomy and annular closure. Review of patient charts through 3 month post op, for analysis of symptomatic lumbar reherniation at the index level.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Records for any subject treated with a Barricaid annular closure device will be considered for inclusion into the study
排除标准
- •Records for any subject treated without a Barricaid annular closure device will be considered for exclusion
结局指标
主要结局
Symptomatic reherniation
时间窗: 3 months post op
Reherniation of the index lumbar disc level, with patient symptoms (back or leg pain)
次要结局
未报告次要终点
研究者
研究点 (1)
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