Trial Outcomes & Findings for A Post Market Study on Dorsal Root Ganglion (DRG) Stimulation in Failed Back Surgery Syndrome (FBSS) (NCT NCT02335216)

Last Updated: 2019-10-16

Results Overview

The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum pain) to 10 (maximum pain).

Recruitment status

TERMINATED

Target enrollment

22 participants

Primary outcome timeframe

Baseline, 3, 6 and 12 Months

Results posted on

2019-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	All Enrolled Subjects All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
Overall Study STARTED	22
Overall Study Received Trial System	16
Overall Study Received Permanent System	13
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Post Market Study on Dorsal Root Ganglion (DRG) Stimulation in Failed Back Surgery Syndrome (FBSS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Enrolled Subjects n=22 Participants All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
Age, Continuous	51 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment Netherlands	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3, 6 and 12 Months

Population: Differences in participants over time is due to early withdrawals and missing data

Outcome measures

Outcome measures
Measure	Subjected Treated With the Permanent Implantable Axium System n=13 Participants All subjects treated with the Axium implantable neurostimulator
Change in Pain Intensity for Overall Pain From Pre-treatment Baseline Baseline	7.7 units on a scale Standard Deviation 1.1
Change in Pain Intensity for Overall Pain From Pre-treatment Baseline 3-Month Visit	2.9 units on a scale Standard Deviation 3.0
Change in Pain Intensity for Overall Pain From Pre-treatment Baseline 6-Month Visit	2.6 units on a scale Standard Deviation 3.6
Change in Pain Intensity for Overall Pain From Pre-treatment Baseline 12-Month Visit	2.4 units on a scale Standard Deviation 2.9

PRIMARY outcome

Timeframe: 3, 6 and 12-Month Visits

Population: Differences in participants over time is due to early withdrawals and missing data

Percent of subjects with at least a 50% reduction. The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum) to 10 (maximum).

Outcome measures

Outcome measures
Measure	Subjected Treated With the Permanent Implantable Axium System n=13 Participants All subjects treated with the Axium implantable neurostimulator
Percentage of Subjects With at Least 50% Pain Reduction 3-Month Visit	9 Participants
Percentage of Subjects With at Least 50% Pain Reduction 6-Month Visit	8 Participants
Percentage of Subjects With at Least 50% Pain Reduction 12-Month Visit	7 Participants

Adverse Events

All Enrolled Subjects

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Enrolled Subjects n=22 participants at risk All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
Hepatobiliary disorders Abdominal pain	4.5% 1/22 • Number of events 1 • All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded from the time of enrollment to study completion or early withdrawal. All-cause mortality was not assessed in this study.

Other adverse events

Other adverse events
Measure	All Enrolled Subjects n=22 participants at risk All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
Injury, poisoning and procedural complications IPG Pocket Pain	4.5% 1/22 • Number of events 1 • All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded from the time of enrollment to study completion or early withdrawal. All-cause mortality was not assessed in this study.
Ear and labyrinth disorders Buzzing noise in left ear	4.5% 1/22 • Number of events 1 • All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded from the time of enrollment to study completion or early withdrawal. All-cause mortality was not assessed in this study.
Injury, poisoning and procedural complications Fall	4.5% 1/22 • Number of events 1 • All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded from the time of enrollment to study completion or early withdrawal. All-cause mortality was not assessed in this study.
Nervous system disorders Irritated ganglion	4.5% 1/22 • Number of events 1 • All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded from the time of enrollment to study completion or early withdrawal. All-cause mortality was not assessed in this study.
Injury, poisoning and procedural complications Loss of stimulation	4.5% 1/22 • Number of events 1 • All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded from the time of enrollment to study completion or early withdrawal. All-cause mortality was not assessed in this study.
Infections and infestations Wound Infection	9.1% 2/22 • Number of events 2 • All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded from the time of enrollment to study completion or early withdrawal. All-cause mortality was not assessed in this study.
Injury, poisoning and procedural complications Dural puncture	13.6% 3/22 • Number of events 3 • All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded from the time of enrollment to study completion or early withdrawal. All-cause mortality was not assessed in this study.
Injury, poisoning and procedural complications Hematoma/Infection	4.5% 1/22 • Number of events 1 • All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded from the time of enrollment to study completion or early withdrawal. All-cause mortality was not assessed in this study.

Additional Information

Roni Diaz

St. Jude Medical

Phone: +19723098601

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60