NCT05277818招募中不适用
Clinical Follow-up of the DIVA® Device in Lumbar Disc Herniation Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- SC Medica
- 入组人数
- 822
- 试验地点
- 1
- 主要终点
- Rates of patients requiring reoperation for any cause (excluding trauma) on the lumbar spine 5 years postoperatively.
研究概览
简要总结
Observational, ambispective, longitudinal, comparative, open, multicentric study.
The main objective is to compare the performance of care in patients operated with and without DIVA®.
详细描述
The primary endpoint is the reoperation for any cause (excluding trauma) on the lumbar spine.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient, having undergone surgery for a degenerative or traumatic mono-segmental lumbar disc herniation, without any other associated pathology, operated with or without a DIVA® implant;
- •Patient operated for at least 12 months;
- •Patient able to understand the information related to the study;
- •Patient having indicated his/her non-opposition to the collection of his/her personal data.
排除标准
- •History of pathologies, malformations or surgical interventions on the spine;
- •Patient belonging to the first 30 operated by the surgeon with the DIVA® implant;
- •Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision);
- •Patient not benefiting from a social security scheme.
结局指标
主要结局
Rates of patients requiring reoperation for any cause (excluding trauma) on the lumbar spine 5 years postoperatively.
时间窗: 5 years
The main analysis will compare the rates of patients requiring reoperation due to any cause (excluding trauma) on the lumbar spine 5 years after surgery between the group with DIVA® and the group without DIVA®, using a Chi-square test.
次要结局
未报告次要终点
研究者
研究点 (1)
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