SAIF: Sacroiliac Fusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 主要终点
- SI Joint Fusion
研究概览
简要总结
The purpose of the SAIF study is to evaluate the SImmetry Sacroiliac Joint Fusion System for fusion and pain reduction of the SI joint.
详细描述
This is a prospective, non-randomized, single center study to collect data on fusion and pain reduction following implantation of the SImmetry device. Up to 15 total subjects will be implanted and followed for 24 months. Data will be collected pre-operatively, at implant, discharge, and at specified follow-up time points (6 weeks, 3 months, 6 months, 12 months, 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
- •Subjects must be indicated for the SImmetry device according to the approved SImmetry labeling
- •Subject has three (3) positive (experiences pain) Provocative Tests for SIJ pain; for example, Compression, Thigh Thrust, FABER, Distraction or Gaenslen's
- •Subject has documentation of failed, non-operative management of SIJ pain for ≥ 6 months prior to surgery; for example, use of medications, braces, SI belts, orthotics, physical therapy or manual manipulation
- •The subject has one (1) positive diagnostic SIJ injection, resulting in a ≥50% decrease in pain from the anesthetic portion of the injection
- •The subject has VAS back pain score of ≥ 60 mm
- •The subject has an ODI ≥ 40%
- •The subject is at least 18 years of age and skeletally mature
- •The subject agrees and is able to comply with study requirements
排除标准
- •Subjects contraindicated per the cleared labeling will be excluded from participation in the study
- •The subject has pelvic soft tissue or bony tumors
- •The subject has had any trauma causing fracture of the sacrum or iliac bones or has had spinal trauma leading to a neurological deficit
- •The subject has a history of a central nervous system (CNS) disorder(s)
- •The subject is pregnant or is planning on becoming pregnant in the next two years
- •The subject has chemical dependency problems as evidenced by a history of drug abuse which is documented in their past medical history or is elicited from an interview
- •The subject has a history of significant emotional or psychosocial disturbance (anxiety attacks, obsessive/compulsive disorders, depression or schizophrenia) as documented in their past medical history or elicited by an interview
结局指标
主要结局
SI Joint Fusion
时间窗: 12 months
Confirmed fusion of the SI joint at 12 and 24 months, defined as as presence of a continuous segment of solid bridging bone that extends from the sacrum to the ilium.
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
- SI Joint Pain Reduction(12 and 24 months)