Real-World Outcomes Study on Subjects Treated With Radiofrequency Ablation
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.
⁃ 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