Trial Outcomes & Findings for A Safety and Effectiveness Trial of Spinal Cord Stimulation of the Dorsal Root Ganglion for Chronic Lower Limb Pain (NCT NCT01923285)
NCT ID: NCT01923285
Last Updated: 2020-11-24
Results Overview
Treatment Success is defined as at least 50% lower limb pain relief (VAS score reduction) at the end of trial phase, received at least 50% lower limb pain relief at the 3-month visit post implant, and the absence of a stimulation related neurological deficit. Pain scores were measured using Visual Analog Scale (VAS). The VAS score ranges from 0-100 mm with a higher score indicating higher pain intensity ( 0 representing "No Pain" and 100 mm representing "Worst Imaginable Pain").
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
152 participants
Primary outcome timeframe
3 months
Results posted on
2020-11-24
Participant Flow
Participant milestones
| Measure |
AXIUM Neurostimulator System
The AXIUM Neurostimulator System is an investigational spinal cord stimulation device that is designed to stimulate the dorsal root ganglion (DRG) of the spine located on the back surface of the spinal cord where nerves exit the backbone. The device has 2 parts that are placed surgically (implanted) : 1) a pulse generator which is placed under the skin in the buttocks or abdomen, and 2) up to four wires (leads) that have one end attached to the pulse generator, and the other end secured to the tissue near the target treatment area.
AXIUM Neurostimulator System
|
Control Spinal Cord Stimulation Device
The Control Spinal Cord Stimulation Device is a commercially available spinal cord stimulator indicated for the treatment of chronic lower limb pain.
Control Spinal Cord Stimulation Device
|
|---|---|---|
|
Overall Study
STARTED
|
76
|
76
|
|
Overall Study
Modified Intent-to-treat
|
73
|
73
|
|
Overall Study
COMPLETED
|
69
|
70
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
| Measure |
AXIUM Neurostimulator System
The AXIUM Neurostimulator System is an investigational spinal cord stimulation device that is designed to stimulate the dorsal root ganglion (DRG) of the spine located on the back surface of the spinal cord where nerves exit the backbone. The device has 2 parts that are placed surgically (implanted) : 1) a pulse generator which is placed under the skin in the buttocks or abdomen, and 2) up to four wires (leads) that have one end attached to the pulse generator, and the other end secured to the tissue near the target treatment area.
AXIUM Neurostimulator System
|
Control Spinal Cord Stimulation Device
The Control Spinal Cord Stimulation Device is a commercially available spinal cord stimulator indicated for the treatment of chronic lower limb pain.
Control Spinal Cord Stimulation Device
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
6
|
Baseline Characteristics
A Safety and Effectiveness Trial of Spinal Cord Stimulation of the Dorsal Root Ganglion for Chronic Lower Limb Pain
Baseline characteristics by cohort
| Measure |
AXIUM Neurostimulator System
n=76 Participants
The AXIUM Neurostimulator System is an investigational spinal cord stimulation device that is designed to stimulate the dorsal root ganglion (DRG) of the spine located on the back surface of the spinal cord where nerves exit the backbone. The device has 2 parts that are placed surgically (implanted) : 1) a pulse generator which is placed under the skin in the buttocks or abdomen, and 2) up to four wires (leads) that have one end attached to the pulse generator, and the other end secured to the tissue near the target treatment area.
AXIUM Neurostimulator System
|
Control Spinal Cord Stimulation Device
n=76 Participants
The Control Spinal Cord Stimulation Device is a commercially available spinal cord stimulator indicated for the treatment of chronic lower limb pain.
Control Spinal Cord Stimulation Device
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.2 Years
n=93 Participants
|
53 Years
n=4 Participants
|
53 Years
n=27 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
76 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
76 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
72 Participants
n=93 Participants
|
70 Participants
n=4 Participants
|
142 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
4 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
72 Participants
n=93 Participants
|
68 Participants
n=4 Participants
|
140 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
76 participants
n=93 Participants
|
76 participants
n=4 Participants
|
152 participants
n=27 Participants
|
|
Body Mass Index (BMI)
|
29.9 kg/m2
n=93 Participants
|
27.9 kg/m2
n=4 Participants
|
29.9 kg/m2
n=27 Participants
|
|
Primary Diagnosis
Complex Regional Pain Syndrome
|
44 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
87 Participants
n=27 Participants
|
|
Primary Diagnosis
Peripheral Causalgia
|
32 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
|
Duration of Lower Limb Pain
|
5.0 Years
n=93 Participants
|
4.5 Years
n=4 Participants
|
5.0 Years
n=27 Participants
|
|
Primary Region of Pain
Region 2 - Right Groin
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Primary Region of Pain
Region 3 - Left Groin
|
4 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Primary Region of Pain
Region 4 - Right Buttock
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Primary Region of Pain
Region 5 - Left Buttock
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Primary Region of Pain
Region 6 - Right Leg
|
14 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Primary Region of Pain
Region 7 - Left Leg
|
8 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Primary Region of Pain
Region 8 - Right Foot
|
21 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Primary Region of Pain
Region 9 - Left Foot
|
22 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Subjects excluded since they do not have evaluable data: Axium=4, Control=3. Seven subjects in the MITT analysis have no evaluable data for the study endpoints due to withdrawing prior to the 3-mo study visit and did not meeting criteria for treatment failure/success upon study exit.
Treatment Success is defined as at least 50% lower limb pain relief (VAS score reduction) at the end of trial phase, received at least 50% lower limb pain relief at the 3-month visit post implant, and the absence of a stimulation related neurological deficit. Pain scores were measured using Visual Analog Scale (VAS). The VAS score ranges from 0-100 mm with a higher score indicating higher pain intensity ( 0 representing "No Pain" and 100 mm representing "Worst Imaginable Pain").
Outcome measures
| Measure |
AXIUM Neurostimulator System
n=69 Participants
The AXIUM Neurostimulator System is an investigational spinal cord stimulation device that is designed to stimulate the dorsal root ganglion (DRG) of the spine located on the back surface of the spinal cord where nerves exit the backbone. The device has 2 parts that are placed surgically (implanted) : 1) a pulse generator which is placed under the skin in the buttocks or abdomen, and 2) up to four wires (leads) that have one end attached to the pulse generator, and the other end secured to the tissue near the target treatment area.
AXIUM Neurostimulator System
|
Control Spinal Cord Stimulation Device
n=70 Participants
The Control Spinal Cord Stimulation Device is a commercially available spinal cord stimulator indicated for the treatment of chronic lower limb pain.
Control Spinal Cord Stimulation Device
|
|---|---|---|
|
Primary Composite Endpoint - Treatment Success
|
81.2 percentage of subjects
Interval 69.9 to 89.6
|
55.7 percentage of subjects
Interval 43.3 to 67.6
|
SECONDARY outcome
Timeframe: 3 monthsPositional effects on paresthesia intensities at 3 months in the Control group versus the Treatment Group. This endpoint will compare the difference in paresthesia scores upright and supine between the AXIUM and Control groups. Paresthesia intensity was rated by subjects using a paresthesia intensity rating scale. Subjects rated the intensity of their perception of paresthesia, while upright and supine, on an 11-point numeric rating scale from 0 representing "No feeling" to 10 "Very intense." Perceived paresthesia intensity difference between supine and upright positions was calculated and averaged across each group.
Outcome measures
| Measure |
AXIUM Neurostimulator System
n=56 Participants
The AXIUM Neurostimulator System is an investigational spinal cord stimulation device that is designed to stimulate the dorsal root ganglion (DRG) of the spine located on the back surface of the spinal cord where nerves exit the backbone. The device has 2 parts that are placed surgically (implanted) : 1) a pulse generator which is placed under the skin in the buttocks or abdomen, and 2) up to four wires (leads) that have one end attached to the pulse generator, and the other end secured to the tissue near the target treatment area.
AXIUM Neurostimulator System
|
Control Spinal Cord Stimulation Device
n=53 Participants
The Control Spinal Cord Stimulation Device is a commercially available spinal cord stimulator indicated for the treatment of chronic lower limb pain.
Control Spinal Cord Stimulation Device
|
|---|---|---|
|
Positional Effects on Paresthesia Intensities
|
-0.1 score on a scale
Standard Deviation 1.6
|
1.8 score on a scale
Standard Deviation 3.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsTreatment Success is defined as a reduction in pain score greater than or equal to 50 percent and the absence of a stimulation related neurological deficit. Pain scores were measured using Visual Analog Scale (VAS). The VAS score ranges from 0-100 mm with a higher score indicating higher pain intensity ( 0 representing "No Pain" and 100 mm representing "Worst Imaginable Pain").
Outcome measures
| Measure |
AXIUM Neurostimulator System
n=61 Participants
The AXIUM Neurostimulator System is an investigational spinal cord stimulation device that is designed to stimulate the dorsal root ganglion (DRG) of the spine located on the back surface of the spinal cord where nerves exit the backbone. The device has 2 parts that are placed surgically (implanted) : 1) a pulse generator which is placed under the skin in the buttocks or abdomen, and 2) up to four wires (leads) that have one end attached to the pulse generator, and the other end secured to the tissue near the target treatment area.
AXIUM Neurostimulator System
|
Control Spinal Cord Stimulation Device
n=54 Participants
The Control Spinal Cord Stimulation Device is a commercially available spinal cord stimulator indicated for the treatment of chronic lower limb pain.
Control Spinal Cord Stimulation Device
|
|---|---|---|
|
Primary Composite Endpoint - Treatment Success for Only Those Subjects With a Permanent Implant
|
93.3 percentage of subjects
Interval 83.3 to 98.2
|
72.2 percentage of subjects
Interval 58.4 to 83.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsTreatment Success is defined as a reduction in pain score greater than or equal to 50 percent and the absence of a stimulation related neurological deficit. Pain scores were measured using Visual Analog Scale (VAS). The VAS score ranges from 0-100 mm with a higher score indicating higher pain intensity ( 0 representing "No Pain" and 100 mm representing "Worst Imaginable Pain").
Outcome measures
| Measure |
AXIUM Neurostimulator System
n=57 Participants
The AXIUM Neurostimulator System is an investigational spinal cord stimulation device that is designed to stimulate the dorsal root ganglion (DRG) of the spine located on the back surface of the spinal cord where nerves exit the backbone. The device has 2 parts that are placed surgically (implanted) : 1) a pulse generator which is placed under the skin in the buttocks or abdomen, and 2) up to four wires (leads) that have one end attached to the pulse generator, and the other end secured to the tissue near the target treatment area.
AXIUM Neurostimulator System
|
Control Spinal Cord Stimulation Device
n=51 Participants
The Control Spinal Cord Stimulation Device is a commercially available spinal cord stimulator indicated for the treatment of chronic lower limb pain.
Control Spinal Cord Stimulation Device
|
|---|---|---|
|
Primary Composite Endpoint - Treatment Success for Only Those Subjects With a Permanent Implant
|
86 percentage of subjects
Interval 74.2 to 93.7
|
68.6 percentage of subjects
Interval 54.1 to 80.9
|
Adverse Events
AXIUM Neurostimulator System
Serious events: 8 serious events
Other events: 5 other events
Deaths: 0 deaths
Control Spinal Cord Stimulation Device
Serious events: 15 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AXIUM Neurostimulator System
n=76 participants at risk
The AXIUM Neurostimulator System is an investigational spinal cord stimulation device that is designed to stimulate the dorsal root ganglion (DRG) of the spine located on the back surface of the spinal cord where nerves exit the backbone. The device has 2 parts that are placed surgically (implanted) : 1) a pulse generator which is placed under the skin in the buttocks or abdomen, and 2) up to four wires (leads) that have one end attached to the pulse generator, and the other end secured to the tissue near the target treatment area.
AXIUM Neurostimulator System
|
Control Spinal Cord Stimulation Device
n=76 participants at risk
The Control Spinal Cord Stimulation Device is a commercially available spinal cord stimulator indicated for the treatment of chronic lower limb pain.
Control Spinal Cord Stimulation Device
|
|---|---|---|
|
Blood and lymphatic system disorders
Abnormal blood chemistry
|
1.3%
1/76 • Number of events 1 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
0.00%
0/76 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
|
Musculoskeletal and connective tissue disorders
Lower extremity/bilateral leg pain
|
0.00%
0/76 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
1.3%
1/76 • Number of events 1 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
|
Psychiatric disorders
Substance relayed disorder/overdose or withdrawal
|
0.00%
0/76 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
2.6%
2/76 • Number of events 2 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
|
Infections and infestations
Wound infection
|
0.00%
0/76 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
2.6%
2/76 • Number of events 2 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.6%
2/76 • Number of events 2 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
0.00%
0/76 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
|
Musculoskeletal and connective tissue disorders
Injury/ADL
|
1.3%
1/76 • Number of events 1 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
1.3%
1/76 • Number of events 1 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
|
Musculoskeletal and connective tissue disorders
Bone infection
|
1.3%
1/76 • Number of events 1 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
0.00%
0/76 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
|
Cardiac disorders
Cardiac Arrhythmia
|
1.3%
1/76 • Number of events 1 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
0.00%
0/76 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
|
Gastrointestinal disorders
Nausea/vomiting
|
1.3%
1/76 • Number of events 1 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
0.00%
0/76 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
|
Surgical and medical procedures
Joint or muscle surgery
|
1.3%
1/76 • Number of events 1 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
0.00%
0/76 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
|
Cardiac disorders
Hypertension
|
0.00%
0/76 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
1.3%
1/76 • Number of events 1 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
|
Musculoskeletal and connective tissue disorders
Bone fracture
|
0.00%
0/76 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
1.3%
1/76 • Number of events 1 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
|
Cardiac disorders
Cardiac valve
|
0.00%
0/76 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
1.3%
1/76 • Number of events 1 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/76 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
1.3%
1/76 • Number of events 1 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
|
Skin and subcutaneous tissue disorders
Dermatologic
|
0.00%
0/76 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
1.3%
1/76 • Number of events 1 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
|
General disorders
Eyes or ears or nose or throat
|
0.00%
0/76 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
1.3%
1/76 • Number of events 1 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
|
Hepatobiliary disorders
Cholecystectomy
|
0.00%
0/76 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
1.3%
1/76 • Number of events 1 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/76 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
1.3%
1/76 • Number of events 1 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
|
Infections and infestations
Systemic infection or general
|
0.00%
0/76 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
1.3%
1/76 • Number of events 1 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
|
Injury, poisoning and procedural complications
Fall injury
|
0.00%
0/76 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
1.3%
1/76 • Number of events 1 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/76 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
1.3%
1/76 • Number of events 1 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
|
Hepatobiliary disorders
Cirrhosis
|
0.00%
0/76 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
1.3%
1/76 • Number of events 1 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
|
Musculoskeletal and connective tissue disorders
Trunk or rib pain
|
0.00%
0/76 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
1.3%
1/76 • Number of events 1 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
Other adverse events
| Measure |
AXIUM Neurostimulator System
n=76 participants at risk
The AXIUM Neurostimulator System is an investigational spinal cord stimulation device that is designed to stimulate the dorsal root ganglion (DRG) of the spine located on the back surface of the spinal cord where nerves exit the backbone. The device has 2 parts that are placed surgically (implanted) : 1) a pulse generator which is placed under the skin in the buttocks or abdomen, and 2) up to four wires (leads) that have one end attached to the pulse generator, and the other end secured to the tissue near the target treatment area.
AXIUM Neurostimulator System
|
Control Spinal Cord Stimulation Device
n=76 participants at risk
The Control Spinal Cord Stimulation Device is a commercially available spinal cord stimulator indicated for the treatment of chronic lower limb pain.
Control Spinal Cord Stimulation Device
|
|---|---|---|
|
General disorders
Side effect/Procedure medication
|
6.6%
5/76 • Number of events 5 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
6.6%
5/76 • Number of events 5 • Adverse events were collected from the time of subject enrollment through completion of study follow-up or early discontinuation, whichever occured first, an average of 1 year.
An AE is an untoward medical occurrence in a patient or subject implanted with a study device whether or not the event has causal relationship to the device; can be any unfavorable or unintended sign, symptom, disease temporally associated with device use. An AE is serious if it meets any of the following: immediately life threatening, results in disability, requires invasive intervention to preclude permanent impairment or death, results in or prolongs hospitalization, or results in death.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place