Trial Outcomes & Findings for A Post Market Study to Assess the Spinal Modulation Dorsal Root Ganglion Stimulator System in Chronic Post Surgical Pain (NCT NCT02335229)

Last Updated: 2019-04-29

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

30 participants

Primary outcome timeframe

Baseline, 3, 6, 12 and 24-Month Visits

Results posted on

2019-04-29

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	30
Overall Study Received Trial System	10
Overall Study Received Permanent System	26
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Post Market Study to Assess the Spinal Modulation Dorsal Root Ganglion Stimulator System in Chronic Post Surgical Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Enrolled Subjects n=30 Participants All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
Age, Continuous	50 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	17 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	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Netherlands	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3, 6, 12 and 24-Month Visits

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

Outcome measures

Outcome measures
Measure	Subjects Treated With the Permanent Implantable Axium System n=30 Participants All subjects treated with the Axium implantable neurostimulator
Change in Pain Intensity for Overall Pain From Pre-treatment Baseline Baseline	6.7 units on a scale Standard Deviation 2.0
Change in Pain Intensity for Overall Pain From Pre-treatment Baseline 3-Month Visit	5.2 units on a scale Standard Deviation 2.5
Change in Pain Intensity for Overall Pain From Pre-treatment Baseline 6-Month Visit	3.9 units on a scale Standard Deviation 2.7
Change in Pain Intensity for Overall Pain From Pre-treatment Baseline 12-Month Visit	4.8 units on a scale Standard Deviation 2.6
Change in Pain Intensity for Overall Pain From Pre-treatment Baseline 24-Month Visit	4.8 units on a scale Standard Deviation 2.0

PRIMARY outcome

Timeframe: 3, 6, 12 and 24-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	Subjects Treated With the Permanent Implantable Axium System n=30 Participants All subjects treated with the Axium implantable neurostimulator
Percentage of Subjects With at Least 50% Pain Reduction 3-Month Visit	6 Participants
Percentage of Subjects With at Least 50% Pain Reduction 6-Month Visit	5 Participants
Percentage of Subjects With at Least 50% Pain Reduction 12-Month Visit	5 Participants
Percentage of Subjects With at Least 50% Pain Reduction 24-Month Visit	6 Participants

Adverse Events

All Enrolled Subjects

Serious events: 4 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Enrolled Subjects n=30 participants at risk All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
Product Issues Increasing pain due to lead failure/malfunction	3.3% 1/30 • Number of events 1 • Adverse events were collected from Informed Consent through study exit (24-Month visit).
Investigations Low blood sodium level	3.3% 1/30 • Number of events 1 • Adverse events were collected from Informed Consent through study exit (24-Month visit).
Injury, poisoning and procedural complications Lead damaged due to accidental incision	3.3% 1/30 • Number of events 1 • Adverse events were collected from Informed Consent through study exit (24-Month visit).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant tumor	3.3% 1/30 • Number of events 1 • Adverse events were collected from Informed Consent through study exit (24-Month visit).

Other adverse events

Other adverse events
Measure	All Enrolled Subjects n=30 participants at risk All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
Product Issues Broken lead	3.3% 1/30 • Number of events 1 • Adverse events were collected from Informed Consent through study exit (24-Month visit).
Product Issues IPG migration	3.3% 1/30 • Number of events 1 • Adverse events were collected from Informed Consent through study exit (24-Month visit).
Product Issues Lead migration	6.7% 2/30 • Number of events 2 • Adverse events were collected from Informed Consent through study exit (24-Month visit).
General disorders Pain at IPG Pocket	10.0% 3/30 • Number of events 3 • Adverse events were collected from Informed Consent through study exit (24-Month visit).
Product Issues Partial loss of stimulation and pain at IPG pocket	3.3% 1/30 • Number of events 1 • Adverse events were collected from Informed Consent through study exit (24-Month visit).
Musculoskeletal and connective tissue disorders Back pain	6.7% 2/30 • Number of events 2 • Adverse events were collected from Informed Consent through study exit (24-Month visit).
Vascular disorders Bleeding/Hematoma	13.3% 4/30 • Number of events 4 • Adverse events were collected from Informed Consent through study exit (24-Month visit).
Injury, poisoning and procedural complications Dura Puncture	3.3% 1/30 • Number of events 1 • Adverse events were collected from Informed Consent through study exit (24-Month visit).
Injury, poisoning and procedural complications Foot injury	3.3% 1/30 • Number of events 1 • Adverse events were collected from Informed Consent through study exit (24-Month visit).
General disorders Increased pain in the target area	3.3% 1/30 • Number of events 1 • Adverse events were collected from Informed Consent through study exit (24-Month visit).
Nervous system disorders Kicking movement during the night	3.3% 1/30 • Number of events 1 • Adverse events were collected from Informed Consent through study exit (24-Month visit).
Product Issues Loss of stimulation	6.7% 2/30 • Number of events 2 • Adverse events were collected from Informed Consent through study exit (24-Month visit).
Musculoskeletal and connective tissue disorders Shoulder pain	3.3% 1/30 • Number of events 1 • Adverse events were collected from Informed Consent through study exit (24-Month visit).
Injury, poisoning and procedural complications Spinal Tap	3.3% 1/30 • Number of events 1 • Adverse events were collected from Informed Consent through study exit (24-Month visit).

Additional Information

Jennifer Duggan

St. Jude Medical

Phone: +32(0)27746827

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60