VIA Disc NP Registry 3.0
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 24
- 主要终点
- Numeric Pain Rating Scale (NPRS)
研究概览
简要总结
Registry is to observe and trend patterns of care and outcomes for patients treated with VIA Disc NP.
详细描述
The Registry is intended to collect data for patients having received treatment with VIA Disc NP.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 是
入选标准
- •Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol
- •18 years of age or older
- •Literate, able to speak and read English, and able to complete questionnaires independently
- •Subject received a VIA Disc NP injection with 1 or more levels within 90 days of the baseline visit.
排除标准
- •Participant did not receive VIA Disc NP injection
- •Participant is pregnant (self-reported, no special study pregnancy testing needed).
- •Any contraindications as noted in the VIA Disc NP Instructions for Use
- •Previous treatment with VIA Disc NP
研究组 & 干预措施
VIA Disc NP
Patients meeting study criteria receiving Vivex VIA Disc NP injection as treatment
干预措施: VIA Disc NP (Other)
结局指标
主要结局
Numeric Pain Rating Scale (NPRS)
时间窗: 1, 3, 6, & 12 months
Change in Numeric Rating Scale (NRS) scores. Eleven point pain scale used for patient self-reporting of back pain, which ranges from 0 (no pain) to 10 (the worst pain imaginable).
Oswestry Disability Index (ODI)
时间窗: 1, 3, 6, & 12 months
Change in scores from Oswestry Disability Index (ODI). An index comprising of ten categories of function to quantify disability due to back pain.
Patient Satisfaction
时间窗: 1, 3, 6, & 12 months
Patient reported assessment of treatment regarding their experience with the procedure. Four different responses, which range from Not at all satisfied (worst) to Extremely Satisfied (best).
Frequency of Pain Medication Use
时间窗: 1, 3, 6, & 12 months
Assesses the frequency and type of pain medication administered to participants at baseline and follow-up visits scheduled at 1, 3, 6, and 12 months. Data will be collected to track changes in pain medication usage over time.
次要结局
未报告次要终点