NL-OMON55882已完成4 期
*A prospective randomized multicenter study to demonstrate the superiority of the Barricaid® to discectomy for primary lumbar disc herniation*: Extended Follow-Up of the Barricaid® Annular Closure Device (ACD) Randomized Control Trial (RCT) Postmarket Cohort for Lumbar Disc Herniation and Interaction with Other Risk Factors - EUBARD*CP*011
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Only subjects enrolled in the original RCT protocol EUBARD-CP-001 will be
- •eligible for long-term follow-up.
- •Original inclusion criteria included: subjects with radiculopathy (with or
- •without back pain), a positive straight leg raise (L4-5, L5-S1) or femoral
- •stretch test (L1-2, L2-3, L3-4), and a posterior or posterolateral herniation
- •at one level between L1 and S1 with radiographic confirmation of neural
- •compression using MRI who are found to have an anular defect (post discectomy)
- •which measures between 4mm and 6mm tall and between 6mm and 10mm wide, with a
- •minimum posterior disc height of 5mm, and failed at least 6 weeks of
- •conservative treatment.
排除标准
- •Only subjects enrolled in the original RCT protocol EUBARD-CP-001 will be
- •eligible for long-term follow-up.
- •Subjects who have died or withdrawn consent during follow-up of RCT
- •EUBARD-CP-001 will not be included in the patient population eligible for this
- •long-term evaluation.
研究者
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