NCT02179476终止不适用
A Multi-Site Study of the Zyga GlyDer Facet Restoration Device In Subjects With LUmbar FacET Pain Syndrome (DUET)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 8
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
A non-randomized, multi-site feasibility study to evaluate the safety of the Glyder Device in subjects with a history of lumbar facet joint disease (L2 to the sacrum) and successful neural ablation in which the facet joint is confirmed as the source of pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed bilateral facet joint disease demonstrated by a successful facet rhizotomy (neural ablation) within 18 months prior to enrollment
- •Facet pain is limited to one to two levels from L2 to the sacrum and pain is bilateral
- •Two diagnostic injections (MBBs) both resulting in 80% relief to confirm back pain is facetogenic
- •VAS back pain of ≥ 60 mm on a 100 mm scale, and VAS back pain is greater than or equal to the highest VAS leg pain score
- •ODI ≥ 20 points
- •At least six (6) months of non-operative conservative management (Analgesic therapy for a minimum of 2 weeks and a minimum of 4 weeks of NSAID therapy; Supervised exercise and/or physical therapy program-minimum of 12 sessions)
- •At least 22 years of age and skeletally mature
排除标准
- •Pain is from a spinal structure other than facet joints (i.e., disc, hip and SI joint pain are excluded)
- •Osteoporosis or severe osteopenia
- •Lumbar fusion
- •Symptomatic spinal stenosis requiring surgical intervention
- •Prior total disc replacement, fusion, decompressive laminectomy, facetectomy, or placement of a posterior spinous process device
- •Disc herniation requiring surgical intervention
- •The subject has a Body Mass Index (BMI) of greater than 35
- •Planned elective surgery within 12 months
研究组 & 干预措施
Glyder
Experimental
Glyder Facet Restoration Device
干预措施: Glyder (Device)
结局指标
主要结局
Primary Safety Endpoint
时间窗: 6 months
Safety will be evaluated by assessing the incidence of device and/or procedure related serious adverse events.
次要结局
未报告次要终点
研究者
研究点 (8)
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