Evolusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 22
- 主要终点
- SI Joint Fusion
研究概览
简要总结
Sacroiliac joint pain reduction and radiographic evidence of SIJ fusion will be collected to evaluate clinical performance of the SImmetry Sacroiliac Joint Fusion System.
详细描述
This is a prospective, non-randomized post market study designed to evaluate fusion and pain reduction following the use of the SImmetry System. This study will be conducted at up to 40 sites and 250 total subjects will be enrolled and followed through 24 months. Data will be collected pre-operatively, implant, and at specified follow-up time points through 24 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •At least three positive provocative tests for SIJ pain
- •Non-operative management of SIJ pain for ≥ 6 months prior to surgery
- •At least one positive diagnostic SIJ injection resulting in a ≥ 50% decrease in pain
- •VAS back pain score of ≥ 60 mm
- •The subject is at least 18 years of age
排除标准
- •Trauma causing fracture of the sacrum or iliac bones or has had spinal trauma leading to a neurological deficit, or pelvic soft tissue or bony tumors
- •Pregnant or is planning on becoming pregnant in the next two years
- •Chemical dependency abuse problems as evidenced by a history of abusing drugs which is documented in their past medical history or is elicited from an interview.
- •Receiving or seeking worker's compensation, disability remuneration, and/or involved in litigation related to low back or SIJ pain
- •History of significant emotional or psychosocial disturbance
结局指标
主要结局
SI Joint Fusion
时间窗: 12 months
Fusion of the SI joint at 12 and 24 months, defined as presence of a continuous segment of solid bridging bone that extends from the sacrum to the ilium. This will be assessed by an independent core laboratory
SI Joint Pain Reduction
时间窗: 6 Months
SI joint pain reduction evaluated by use of Visual Analogue Scale (VAS) for back pain for comparison of baseline to 6 months.
次要结局
- Quality of Life(6 months)
- SI Joint Pain Reduction(12 months)
- Disability(6 months)