Real-World Outcomes Study on Subjects Treated With Radiofrequency Ablation

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
IonicRF Generator and compatible accessories	IonicRF Generator andcompatible accessories	IonicRF Radiofrequency Generator, along with any country-specific market-released accessory (i.e. electrode, cannula, grounding pad, and adaptor cable) compatible with the IonicRF Generator will be used.

Primary Outcome Measures

Name	Time	Method
Primary Effectiveness Endpoint: Relative Change in Numeric Rating Scale (NRS) From Baseline to 3 Months Follow-up Visit	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	At 3 months	Number of participants with Device- and Procedure-related Serious Adverse Events.

Secondary Outcome Measures

Name	Time	Method

Locations (11): Universitätsmedizin Berlin - Charité Campus Mitte
🇩🇪
Berlin, Germany
AZ Delta vzw
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Roeselare, West Flanders, Belgium
Stichting Rijnstate Ziekenhuis - Arnhem
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Arnhem, Gelderland, Netherlands
Hôpital Privé du Confluent
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Nantes, Pays De La Loire, France
Nevada Advanced Pain Specialists
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Reno, Nevada, United States
Ainsworth Institute of Pain Management
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New York, New York, United States
Nura
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Edina, Minnesota, United States
The Spine & Nerve Center of St Francis Hospital
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Charleston, West Virginia, United States
Krankenhaus Neuwerk Maria von den Aposteln
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Monchengladbach, N. Rhin, Germany
Hospital Clínico Universitario de Valencia
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Valencia, Spain
Hospital Puerta del Mar
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Cadiz, Spain