Prospective SpineJack System Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 261
- 试验地点
- 12
- 主要终点
- Back pain
研究概览
简要总结
This postmarket registry is intended to prospectively collect real world data to support ongoing safety and performance of the SpineJack system.
详细描述
The SpineJack System Registry will employ a prospective, multicenter, observational, consecutive enrollment design. The sample size for this Registry will include at least 400 patients treated for VCFs across approximately 10 sites. A total of 240 patients will be treated with the SpineJack system and 160 patients will be treated with other vertebral augmentation (VA) procedures, such as BKP or VP. Sites within the U.S. may include healthcare professionals (HCPs) that are surgeons, pain physicians and/or interventional radiologists.
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
- •18 years of age or older
- •Understand and sign the informed consent form (as applicable)
- •Exhibit no altered mental status or language barrier that may prevent completion of the patient reported outcome (PRO) surveys following the procedure.
- •VCF diagnosis made and/or confirmed at participating site.
排除标准
- 未提供
结局指标
主要结局
Back pain
时间窗: 12 months post-procedure
The numeric rating scale consists of an eleven-point scale used for patient self-reporting of back pain, which ranges from 0 (no pain) to 10 (the worst pain imaginable).
Radiological outcomes
时间窗: Immediately post-procedure
Adjacent level fractures
Adverse events
时间窗: 12 months post-procedure
1. Incidence of adverse device effects (ADEs) and serious adverse device effects (SADEs) requiring surgical re-intervention or re-treatment at the treated level 2. Incidence of unanticipated ADEs 3. Incidence of procedure-related AEs
Quality of life indices - Roland Morris Disability Questionnaire (RMDQ)
时间窗: 12 months post-procedure
24-item self-report questionnaire used in patients with mild to moderate disability due to acute, sub-acute or chronic low back pain
Patient-Reported Outcomes Measurement Information System (PROMIS Global-10)
时间窗: 12 months post-procedure
10-item questionnaire that is used to assess general domains of health and functioning, including overall physical health, mental health, social health, pain, fatigue and overall perceived quality of life
次要结局
未报告次要终点