Real-World Outcomes Study on Subjects Treated With Radiofrequency Ablation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 11
- 主要终点
- Primary Effectiveness Endpoint: Relative Change in Numeric Rating Scale (NRS) From Baseline to 3 Months Follow-up Visit
研究概览
简要总结
ROSTRA is an international, prospective, non-randomized, single-arm, multi-center, and post-market study to collect real-world safety and effectiveness data on Abbott's IonicRF™Generator and compatible RFA accessories. This post-market study is intended to satisfy EU MDR requirements.
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
- •A. All candidate subjects
- •Subject must provide written informed consent prior to any clinical investigation-related procedure
- •Subject is ≥ 18 years of age
- •Subject has chronic pain > 6 months and was unresponsive to conservative management
- •Subject has pain on an NRS scale of ≥ 6
- •Subject is scheduled for an RFA procedure with the IonicRF generator within 30 days of baseline to treat chronic pain at one anatomical region
- •Subject has stable chronic pain medication use for 30 days
- •Subject is willing and able to comply with the prescribed follow-up evaluations
- •B. Candidate subjects with facet joint pain (lumbar or cervical)
- •Subject has unilateral or bilateral pain on para-spinal palpation and localized pain with extension/lateral bending
- •Subject has facet joint pain confirmed by at least 1 positive medial branch block with 0.5 mL or less of anesthetics (across at least 3 vertebral levels) achieving at least 50% pain relief, with real-time injection of radiographic contrast under fluoroscopic guidance
- •C. Candidate subjects with sacroiliac joint pain
- •Subject has sacroiliac joint pain based on medical history and physical exam
- •Subject has sacroiliac joint pain confirmed by an infiltration of local anesthetics in the posterior part of the sacroiliac joint achieving at least 50% pain relief
- •D. Candidate subjects with radicular pain
- •Subject has radicular pain based on medical history and physical exam
- •Subject has radicular pain confirmed by dermatomal mapping corresponding to at least 1 nerve root level
- •E. Candidate subjects with trigeminal neuralgia
- •Subject has trigeminal pain based on medical history and physical exam
- •Subject did not have any mass effect or stroke causing trigeminal pain confirmed by MRI
- •Subject is ≥ 60 years of age in case of a neurovascular conflict
- •F. Candidate subjects with knee or hip pain
- •Subject has knee or hip pain based on medical history and physical exam
- •Subject has radiographically confirmed osteoarthritis of the hip or knee, or has chronic pain following joint arthroplasty
排除标准
- •A. All candidate subjects
- •Subject is currently participating in another clinical investigation that may confound the results of this study.
- •Ongoing systemic or local infection in the area of the procedure.
- •Recent use of anticoagulants or subject with coagulopathy.
- •Primary complaint of deafferentation pain.
- •Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results.
- •Subject's opioid usage is > 90 morphine equivalents per day.
- •B. Candidate subjects with trigeminal neuralgia
- •Subject has sensory problems
结局指标
主要结局
Primary Effectiveness Endpoint: Relative Change in Numeric Rating Scale (NRS) From Baseline to 3 Months Follow-up Visit
时间窗: Baseline to 3 months
The pain NRS consists of 1 question that will be asked by interviewing the subjects. Patients will be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their average pain over the past 24 hours specific to the area(s) of chronic pain being treated. A higher score indicates greater pain intensity. The presented outcome denotes the mean relative change in NRS score, which was defined as (Baseline score - 3-month follow-up visit score)/ Baseline score\*100%. Higher scores indicate greater relative pain relief. Minimum value is 0% and maximum value is 100%.
Primary Safety Endpoint: Incidence of Device- and Procedure-related Serious Adverse Events
时间窗: At 3 months
Number of participants with Device- and Procedure-related Serious Adverse Events.
次要结局
未报告次要终点