Real-World Outcomes Study on Subjects Treated With Radiofrequency Ablation (ROSTRA)

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Device: IonicRF Generator and compatible accessories

• Study Type: Observational
• Enrollment (Actual): 184

Contacts and Locations

Study Locations

• Belgium
  • West Flanders
    • Roeselare, West Flanders, Belgium, 8800
      • AZ Delta VZW
• France
  • Pays De La Loire
    • Nantes, Pays De La Loire, France, 44200
      • Hôpital Privé du Confluent
• Germany
  • Berlin, Germany, 10117
    • Universitätsmedizin Berlin - Charité Campus Mitte
  • N. Rhin
    • Monchengladbach, N. Rhin, Germany, 41066
      • Krankenhaus Neuwerk Maria von den Aposteln
• Netherlands
  • Gelderland
    • Arnhem, Gelderland, Netherlands, 6815 AD
      • Stichting Rijnstate Ziekenhuis - Arnhem
• Spain
  • Cadiz, Spain, 11009
    • Hospital Puerta del Mar
  • Valencia, Spain, 46010
    • Hospital Clínico Universitario de Valencia
• United States
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Nura
  • Nevada
    • Reno, Nevada, United States, 89511
      • Nevada Advanced Pain Specialists
  • New York
    • New York, New York, United States, 10022
      • Ainsworth Institute of Pain Management
  • West Virginia
    • Charleston, West Virginia, United States, 25301
      • The Spine & Nerve Center of St Francis Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects of all genders from the general chronic pain population referring to the participating pain clinics will be enrolled in the study.

Description

Inclusion Criteria:

A. All candidate subjects

1. Subject must provide written informed consent prior to any clinical investigation-related procedure
2. Subject is ≥ 18 years of age
3. Subject has chronic pain > 6 months and was unresponsive to conservative management
4. Subject has pain on an NRS scale of ≥ 6
5. Subject is scheduled for an RFA procedure with the IonicRF generator within 30 days of baseline to treat chronic pain at one anatomical region
6. Subject has stable chronic pain medication use for 30 days
7. Subject is willing and able to comply with the prescribed follow-up evaluations

B. Candidate subjects with facet joint pain (lumbar or cervical)

1. Subject has unilateral or bilateral pain on para-spinal palpation and localized pain with extension/lateral bending
2. 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

1. Subject has sacroiliac joint pain based on medical history and physical exam
2. 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

1. Subject has radicular pain based on medical history and physical exam
2. Subject has radicular pain confirmed by dermatomal mapping corresponding to at least 1 nerve root level

E. Candidate subjects with trigeminal neuralgia

1. Subject has trigeminal pain based on medical history and physical exam
2. Subject did not have any mass effect or stroke causing trigeminal pain confirmed by MRI
3. Subject is ≥ 60 years of age in case of a neurovascular conflict

F. Candidate subjects with knee or hip pain

1. Subject has knee or hip pain based on medical history and physical exam
2. Subject has radiographically confirmed osteoarthritis of the hip or knee, or has chronic pain following joint arthroplasty

Exclusion Criteria:

A. All candidate subjects

1. Subject is currently participating in another clinical investigation that may confound the results of this study.
2. Ongoing systemic or local infection in the area of the procedure.
3. Recent use of anticoagulants or subject with coagulopathy.
4. Primary complaint of deafferentation pain.
5. 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.
6. Subject's opioid usage is > 90 morphine equivalents per day.

B. Candidate subjects with trigeminal neuralgia

1. Subject has sensory problems

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IonicRF Generator and compatible 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.	Device: IonicRF Generator and compatible accessories; Participants will receive IonicRF lesion generator, along with any country-specific market-released accessory (i.e. electrode, cannula, grounding pad, and adaptor cable) compatible with the IonicRF Generator

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Brad Maruca, Abbott

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2021
• Primary Completion (Actual): December 16, 2022
• Study Completion (Actual): March 8, 2023

Study Registration Dates

• First Submitted: May 4, 2021
• First Submitted That Met QC Criteria: May 4, 2021
• First Posted (Actual): May 5, 2021

Study Record Updates

• Last Update Posted (Actual): November 20, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Chronic pain; IonicRF™ Generator; ABT-CIP-10347; Radio frequency ablation (RFA)
• Other Study ID Numbers: ABT-CIP-10347

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes