Pain
Conditions
Keywords
IonicRF™ Generator, ABT-CIP-10347, Radio frequency ablation (RFA), Chronic pain
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.
Interventions
DEVICEIonicRF 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
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Belgium, France, Germany, Netherlands, Spain, United States
Participant flow
Recruitment details
The study has enrolled 184 subjects at 11 clinical sites in EU and the US. The total duration of the study is expected to be 20 months, including enrollment, data collection from all subjects, and study closeout.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 179 |
| Total | 179 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Additional Chronic Pain Treatment for The Same Anatomical Region | 8 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Other Reasons | 3 |
| Overall Study | Subject and/or Family Request Withdrew Consent | 3 |
| Overall Study | Unsuccessful RFA Procedure | 1 |
Baseline characteristics
| Characteristic | IonicRF Generator and Compatible Accessories |
|---|---|
| Age, Continuous | 59.2 years STANDARD_DEVIATION 13.2 |
| Duration of Chronic Pain (Years) | 9.0 years STANDARD_DEVIATION 8.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 96 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 65 Participants |
| Number of diagnostic blocks provided to participants prior to therapy implementation 0 | 59 Participants |
| Number of diagnostic blocks provided to participants prior to therapy implementation 1 | 47 Participants |
| Number of diagnostic blocks provided to participants prior to therapy implementation 2 | 73 Participants |
| Pain Relief after second diagnostic block | 74.4 units on a scale STANDARD_DEVIATION 17.1 |
| Pain Relief after the first diagnostic block | 71.9 units on a scale STANDARD_DEVIATION 18.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 49 Participants |
| Race (NIH/OMB) White | 120 Participants |
| Sex: Female, Male Female | 127 Participants |
| Sex: Female, Male Male | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 162 |
| other Total, other adverse events | 0 / 162 |
| serious Total, serious adverse events | 0 / 162 |
Outcome results
Primary
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%.
Time frame: Baseline to 3 months
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IonicRF Generator and Compatible Accessories | Primary Effectiveness Endpoint: Relative Change in Numeric Rating Scale (NRS) From Baseline to 3 Months Follow-up Visit | 34.4 score on a scale | Standard Deviation 35.7 |
p-value: <0.0001t-test, 2 sided
Primary
Primary Safety Endpoint: Incidence of Device- and Procedure-related Serious Adverse Events
Number of participants with Device- and Procedure-related Serious Adverse Events.
Time frame: At 3 months
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IonicRF Generator and Compatible Accessories | Primary Safety Endpoint: Incidence of Device- and Procedure-related Serious Adverse Events | 0 Participants |