ACCURATE: A Safety and Effectiveness Trial of Spinal Cord Stimulation of the Dorsal Root Ganglion for Chronic Lower Limb Pain

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01923285
• Collaborator: (none)
• Enrollment: 152
• Locations: 22
• Arms: 2
• Duration (Months): 37
• Patients Per Site: 6.9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the AXIUM Neurostimulator System for the treatment of chronic lower limb pain in persons diagnosed with Complex Regional Pain Syndrome (CRPS) or Peripheral Causalgia (PC).

Condition or Disease	Intervention/Treatment	Phase
Chronic Lower Limb Pain	Device: AXIUM Neurostimulator System; Device: Control Spinal Cord Stimulation Device	N/A

Detailed Description

The ACCURATE study is a prospective, randomized, controlled, multicenter clinical trial designed to assess the safety and efficacy of the Spinal Modulation Axium Neurostimulator System as an aid in the management of chronic, intractable pain of the lower limbs, including unilateral or bilateral pain associated with one of the following conditions: Complex Regional Pain Syndrome (CRPS) or Peripheral Causalgia (also referred to as CRPS Type II).

Enrolled subjects were diagnoses with CRPS or peripheral causalgia; experienced pain for at least six months; and failed to achieve adequate pain relief from at least two prior pharmacologic treatments.

All subjects had a temporary trial neurostimulator (TNS). If the subject was a treatment success at the end of TNS they were scheduled for the fully implantable neurostimulator (INS) implant procedure. If not, subjects were exited from the study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 152 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Randomized, Multi-Center, Controlled Clinical Trial to Assess the Safety and Efficacy of the Spinal Modulation™ AXIUM™ Neurostimulator System in the Treatment of Chronic Pain (ACCURATE Trial)
• Study Start Date: Aug 1, 2013
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: AXIUM Neurostimulator System; Other Names: DRG Stimulation
Active Comparator: 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.	Device: Control Spinal Cord Stimulation Device; Other Names: SCS

Outcome Measures

Primary Outcome Measures

1. Primary Composite Endpoint - Treatment Success [3 months]

   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").

Secondary Outcome Measures

1. Positional Effects on Paresthesia Intensities [3 months]

   Positional 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.

Other Outcome Measures

1. Primary Composite Endpoint - Treatment Success for Only Those Subjects With a Permanent Implant [3 months]

   Treatment 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").

2. Primary Composite Endpoint - Treatment Success for Only Those Subjects With a Permanent Implant [12 months]

   Treatment 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").

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject is male or female between the ages of 22 and 75 years

2. Subject is able and willing to comply with the follow-up schedule and protocol

3. Subject has chronic, intractable pain of the lower limb(s) for at least 6 months

4. Subjects are diagnosed with complex regional pain syndrome (CRPS) and/or peripheral causalgia

5. Subjects have a minimum Visual Analog Scale (VAS) greater than or equal to 60 mm in the area of greatest pain in the lower limbs.

6. Subject has failed to achieve adequate pain relief from at least 2 prior pharmacologic treatments from at least 2 different drugs classes

7. Subject has had stable neurologic function in the past 30 days

8. In the opinion of the Investigator, the subject is psychologically appropriate for the implantation of an active implantable medical device

9. Subject is able to provide written informed consent

Exclusion Criteria:

1. Back pain is the greatest region of pain as measured on the baseline VAS.

2. Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control

3. Subject has exhibited escalating or changing pain condition within the past 30 days as evidenced by Investigator examination

4. Subject is currently involved in medically related litigation, including workers compensation

5. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days

6. Subject's pain medication(s) dosage(s) are not stable for at least 30 days

7. Subject has had radiofrequency treatment of an intended target Dorsal Root Ganglion within the past 3 months

8. Subject has previously failed spinal cord stimulation therapy

9. Subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump or subject requires magnetic resonance imaging (MRIs) or diathermy

10. Subject has pain only within a cervical distribution

11. Subject has cognitive, physical or sensory impairment that, in the opinion of the Investigator, may limit their ability to operate the device

12. Subject currently has an indwelling device that may pose an increased risk of infection

13. Subject currently has an active systemic infection.

14. Subject has, in the opinion of the investigator, a medical comorbidity that contraindicates placement of an active medical device

15. Subject has participated in another clinical investigation within 30 days

16. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the Investigator, precludes participation

17. Subject has been diagnosed with cancer in the past 2 years

18. Imaging (MRI, CT, x-ray) findings within the last 12 months that, in the Investigator's opinion, contraindicates lead placement

19. Subject is a prisoner

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HOPE Research - TPC	Phoenix	Arizona	United States	85018
2	Pain Clinic of Monterey Bay	Aptos	California	United States	94025
3	Coastal Pain Research	Carlsbad	California	United States	94025
4	Neurovations, Inc.	Napa	California	United States	94558
5	Newport Beach Headache and Pain	Newport Beach	California	United States	94025
6	Eisenhower Medical Center	Rancho Mirage	California	United States	94025
7	Orthopaedic Pain Specialists	Santa Monica	California	United States	94025
8	IPM Medical Group, Inc.	Walnut Creek	California	United States	94598
9	Florida Pain Institute	Merritt Island	Florida	United States	32953
10	Holy Cross Hospital Orthopedic Institute	Oakland Park	Florida	United States	33334
11	Drug Studies of America	Marietta	Georgia	United States	30060
12	Comprehensive Pain and Rehabilitation	Pascagoula	Mississippi	United States	39581
13	Pain Management Associates	Independence	Missouri	United States	64055
14	HOPE Research - LVSP	Las Vegas	Nevada	United States	89106
15	Premier Pain Center	Shrewsbury	New Jersey	United States	07702
16	The Center for Clinical Research	Winston-Salem	North Carolina	United States	27103
17	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
18	Clinical Trials of South Carolina	Charleston	South Carolina	United States	29406
19	Southeastern Spine Institute	Mount Pleasant	South Carolina	United States	29464
20	Houston Pain Centers	Houston	Texas	United States	77030
21	Center for Pain Relief	Charleston	West Virginia	United States	25301
22	Center for Pain Relief Tri-State	Huntington	West Virginia	United States	25702

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Study Director: Robyn Capobianco, PhD, Abbott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT01923285
• Other Study ID Numbers: 03-SMI-2012
• First Posted: Aug 15, 2013
• Last Update Posted: Nov 24, 2020
• Last Verified: Nov 1, 2020

Study Results

Participant Flow

Arm/Group Title	AXIUM Neurostimulator System	Control Spinal Cord Stimulation Device
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	76	76
Modified Intent-to-treat	73	73
COMPLETED	69	70
NOT COMPLETED	7	6

Baseline Characteristics

Arm/Group Title	AXIUM Neurostimulator System	Control Spinal Cord Stimulation Device	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	76	76	152
Age (Years) [Median (Full Range) ]
Median (Full Range) [Years]	53.2	53	53
Sex: Female, Male (Count of Participants)
Female	39 51.3%	37 48.7%	76 50%
Male	37 48.7%	39 51.3%	76 50%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	0 0%	1 1.3%	1 0.7%
Black or African American	2 2.6%	3 3.9%	5 3.3%
Native Hawaiian or Other Pacific Islander	1 1.3%	0 0%	1 0.7%
White	72 94.7%	70 92.1%	142 93.4%
Other	1 1.3%	2 2.6%	3 2%
Race/Ethnicity, Customized (Count of Participants)
Hispanic or Latino	4 5.3%	8 10.5%	12 7.9%
Not Hispanic or Latino	72 94.7%	68 89.5%	140 92.1%
Region of Enrollment (participants) [Number]
United States	76 100%	76 100%	152 100%
Body Mass Index (BMI) (kg/m2) [Median (Full Range) ]
Median (Full Range) [kg/m2]	29.9	27.9	29.9
Primary Diagnosis (Count of Participants)
Complex Regional Pain Syndrome	44 57.9%	43 56.6%	87 57.2%
Peripheral Causalgia	32 42.1%	33 43.4%	65 42.8%
Duration of Lower Limb Pain (Years) [Median (Full Range) ]
Median (Full Range) [Years]	5.0	4.5	5.0
Primary Region of Pain (Count of Participants)
Region 2 - Right Groin	4 5.3%	2 2.6%	6 3.9%
Region 3 - Left Groin	4 5.3%	7 9.2%	11 7.2%
Region 4 - Right Buttock	2 2.6%	2 2.6%	4 2.6%
Region 5 - Left Buttock	1 1.3%	2 2.6%	3 2%
Region 6 - Right Leg	14 18.4%	16 21.1%	30 19.7%
Region 7 - Left Leg	8 10.5%	11 14.5%	19 12.5%
Region 8 - Right Foot	21 27.6%	19 25%	40 26.3%
Region 9 - Left Foot	22 28.9%	17 22.4%	39 25.7%

Outcome Measures

1. Primary Outcome

Title	Primary Composite Endpoint - Treatment Success
Description	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").
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	AXIUM Neurostimulator System	Control Spinal Cord Stimulation Device
Arm/Group Description	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	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
Measure Participants	69	70
Number (95% Confidence Interval) [percentage of subjects]	81.2	55.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AXIUM Neurostimulator System, Control Spinal Cord Stimulation Device
	Comments	The primary hypothesis tested was: H0: p1 ≤ p0 - δ vs. H1: p1> p0 - δ, where p0 is the success rate in the Control group, p1 is the success rate in the Axium group, and δ is the non-inferiority margin, which is pre-specified at 10%. If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025.
	Type of Statistical Test	Non-Inferiority
	Comments	The non-inferiority margin, which is pre-specified at 10%. If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	The non-inferiority margin, which is pre-specified at 10%. If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025.
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	AXIUM Neurostimulator System, Control Spinal Cord Stimulation Device
	Comments	The primary hypothesis tested was: H0: p1 ≤ p0 - δ vs. H1: p1> p0 - δ, where p0 is the success rate in the Control group, p1 is the success rate in the Axium group, and δ is the non-inferiority margin, which is pre-specified at 10%.
	Type of Statistical Test	Superiority
	Comments	The non-inferiority margin, which is pre-specified at 10%. If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025
Statistical Test of Hypothesis	p-Value	=0.0004
	Comments
	Method	Chi-squared
	Comments

2. Secondary Outcome

Title	Positional Effects on Paresthesia Intensities
Description	Positional 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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AXIUM Neurostimulator System	Control Spinal Cord Stimulation Device
Arm/Group Description	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	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
Measure Participants	56	53
Mean (Standard Deviation) [score on a scale]	-0.1 (1.6)	1.8 (3.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AXIUM Neurostimulator System, Control Spinal Cord Stimulation Device
	Comments	Secondary endpoint compared the mean differences in upright and supine paresthesia scores between the Axium and Control groups at three months post INS implant. This endpoint was evaluated at a two-sided significance level of 0.05. The primary hypothesis tested was: H0: μ0- μ1≤0 vs. H1: μ0- μ1>0 where μ0 is the mean difference in paresthesia intensities in the Control group and μ1 is the mean difference in the Axium group.
	Type of Statistical Test	Other
	Comments	Comparison of the mean difference. Difference in intensities is calculated as the supine paresthesia intensity minus the upright paresthesia intensity.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.9
	Confidence Interval	(2-Sided) 95%; 1.0 to 2.8
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference in paresthesia intensities is calculated as the supine paresthesia score minus the upright paresthesia score for each subject.

3. Other Pre-specified Outcome

Title	Primary Composite Endpoint - Treatment Success for Only Those Subjects With a Permanent Implant
Description	Treatment 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").
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AXIUM Neurostimulator System	Control Spinal Cord Stimulation Device
Arm/Group Description	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	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
Measure Participants	61	54
Number (95% Confidence Interval) [percentage of subjects]	93.3	72.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AXIUM Neurostimulator System, Control Spinal Cord Stimulation Device
	Comments	The primary hypothesis tested was: H0: p1 ≤ p0 - δ vs. H1: p1> p0 - δ, where p0 is the success rate in the Control group, p1 is the success rate in the Axium group, and δ is the non-inferiority margin, which is pre-specified at 10%.
	Type of Statistical Test	Non-Inferiority
	Comments	If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	AXIUM Neurostimulator System, Control Spinal Cord Stimulation Device
	Comments
	Type of Statistical Test	Superiority
	Comments	If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025.
Statistical Test of Hypothesis	p-Value	=0.0047
	Comments
	Method	Chi-squared
	Comments

4. Other Pre-specified Outcome

Title	Primary Composite Endpoint - Treatment Success for Only Those Subjects With a Permanent Implant
Description	Treatment 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").
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AXIUM Neurostimulator System	Control Spinal Cord Stimulation Device
Arm/Group Description	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	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
Measure Participants	57	51
Number (95% Confidence Interval) [percentage of subjects]	86	68.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AXIUM Neurostimulator System, Control Spinal Cord Stimulation Device
	Comments	The primary hypothesis tested was: H0: p1 ≤ p0 - δ vs. H1: p1> p0 - δ, where p0 is the success rate in the Control group, p1 is the success rate in the Axium group, and δ is the non-inferiority margin, which is pre-specified at 10%.
	Type of Statistical Test	Non-Inferiority
	Comments	If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025.
Statistical Test of Hypothesis	p-Value	0.0003
	Comments
	Method	Non-inferiority
	Comments

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	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.
Arm/Group Title	AXIUM Neurostimulator System		Control Spinal Cord Stimulation Device
Arm/Group Description	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		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
All Cause Mortality
	AXIUM Neurostimulator System		Control Spinal Cord Stimulation Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/76 (0%)		0/76 (0%)
Serious Adverse Events
	AXIUM Neurostimulator System		Control Spinal Cord Stimulation Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/76 (10.5%)		15/76 (19.7%)
Blood and lymphatic system disorders
Abnormal blood chemistry	1/76 (1.3%)	1	0/76 (0%)	0
Cardiac disorders
Cardiac Arrhythmia	1/76 (1.3%)	1	0/76 (0%)	0
Hypertension	0/76 (0%)	0	1/76 (1.3%)	1
Cardiac valve	0/76 (0%)	0	1/76 (1.3%)	1
Heart failure	0/76 (0%)	0	1/76 (1.3%)	1
Gastrointestinal disorders
Nausea/vomiting	1/76 (1.3%)	1	0/76 (0%)	0
Diverticulitis	0/76 (0%)	0	1/76 (1.3%)	1
General disorders
Eyes or ears or nose or throat	0/76 (0%)	0	1/76 (1.3%)	1
Hepatobiliary disorders
Cholecystectomy	0/76 (0%)	0	1/76 (1.3%)	1
Cirrhosis	0/76 (0%)	0	1/76 (1.3%)	1
Infections and infestations
Wound infection	0/76 (0%)	0	2/76 (2.6%)	2
Systemic infection or general	0/76 (0%)	0	1/76 (1.3%)	1
Injury, poisoning and procedural complications
Fall injury	0/76 (0%)	0	1/76 (1.3%)	1
Musculoskeletal and connective tissue disorders
Lower extremity/bilateral leg pain	0/76 (0%)	0	1/76 (1.3%)	1
Arthritis	2/76 (2.6%)	2	0/76 (0%)	0
Injury/ADL	1/76 (1.3%)	1	1/76 (1.3%)	1
Bone infection	1/76 (1.3%)	1	0/76 (0%)	0
Bone fracture	0/76 (0%)	0	1/76 (1.3%)	1
Trunk or rib pain	0/76 (0%)	0	1/76 (1.3%)	1
Psychiatric disorders
Substance relayed disorder/overdose or withdrawal	0/76 (0%)	0	2/76 (2.6%)	2
Skin and subcutaneous tissue disorders
Dermatologic	0/76 (0%)	0	1/76 (1.3%)	1
Cellulitis	0/76 (0%)	0	1/76 (1.3%)	1
Surgical and medical procedures
Joint or muscle surgery	1/76 (1.3%)	1	0/76 (0%)	0
Other (Not Including Serious) Adverse Events
	AXIUM Neurostimulator System		Control Spinal Cord Stimulation Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/76 (6.6%)		5/76 (6.6%)
General disorders
Side effect/Procedure medication	5/76 (6.6%)	5	5/76 (6.6%)	5

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.