Trial Outcomes & Findings for Spinal Cord Stimulation With Precision® System Versus Reoperation for Failed Back Surgery Syndrome (NCT NCT01036529)
NCT ID: NCT01036529
Last Updated: 2020-11-16
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
28 participants
Primary outcome timeframe
3, 6- and 12- months post-index procedure
Results posted on
2020-11-16
Participant Flow
Subjects were recruited for participation from February 2010 to June 2012.
A total of 274 subjects were screened for participation.After screening, 75 subjects were eligible for participation. Of the eligible subjects, 47 declined randomization. A total of 28 subjects were randomized.
Participant milestones
| Measure |
Precision Spinal Cord Stimulator
Precision Spinal Cord Stimulator Intervention
|
Back Surgery
Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
15
|
|
Overall Study
Baseline Visit
|
10
|
13
|
|
Overall Study
Index Procedure
|
10
|
11
|
|
Overall Study
3 Month Follow-up
|
7
|
9
|
|
Overall Study
6 Month Follow-up
|
6
|
7
|
|
Overall Study
12 Month Follow-up
|
4
|
3
|
|
Overall Study
Requested Crossover
|
1
|
2
|
|
Overall Study
Crossover to Other Group
|
1
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
13
|
15
|
Reasons for withdrawal
| Measure |
Precision Spinal Cord Stimulator
Precision Spinal Cord Stimulator Intervention
|
Back Surgery
Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Sponsor study termination
|
11
|
12
|
Baseline Characteristics
Spinal Cord Stimulation With Precision® System Versus Reoperation for Failed Back Surgery Syndrome
Baseline characteristics by cohort
| Measure |
Precision Spinal Cord Stimulator
n=11 Participants
Precision Spinal Cord Stimulation System
|
Back Surgery
n=14 Participants
Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.3 years
STANDARD_DEVIATION 12 • n=5 Participants
|
57 years
STANDARD_DEVIATION 15.3 • n=7 Participants
|
54.9 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3, 6- and 12- months post-index procedureOutcome measures
| Measure |
Precision Spinal Cord Stimulator
n=7 Participants
Precision Spinal Cord Stimulation System
|
Back Surgery
n=9 Participants
Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation
|
|---|---|---|
|
Proportion of Subjects Showing ≥50% Self-reported Leg Pain Relief From Baseline Without Request for Crossover to the Other Treatment
12 month (4 subjects for Stim, 3 subjects Surgery)
|
1.0 proportion of participants
|
0.33 proportion of participants
|
|
Proportion of Subjects Showing ≥50% Self-reported Leg Pain Relief From Baseline Without Request for Crossover to the Other Treatment
3 Month (7 subject Stimulation, 9 Subjects Surger)
|
0.86 proportion of participants
|
0.44 proportion of participants
|
|
Proportion of Subjects Showing ≥50% Self-reported Leg Pain Relief From Baseline Without Request for Crossover to the Other Treatment
6 Month (6 subjects for Stimulation and Surgery)
|
0.5 proportion of participants
|
0.5 proportion of participants
|
Adverse Events
Precision Spinal Cord Stimulator
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Back Surgery
Serious events: 4 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Precision Spinal Cord Stimulator
n=13 participants at risk
Precision Spinal Cord Stimulation System
|
Back Surgery
n=15 participants at risk
Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation
|
|---|---|---|
|
Nervous system disorders
Radicular Pain
|
7.7%
1/13 • Number of events 1
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
0.00%
0/15
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/13
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
6.7%
1/15 • Number of events 1
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/13
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
6.7%
1/15 • Number of events 1
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/13
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
6.7%
1/15 • Number of events 1
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/13
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
6.7%
1/15 • Number of events 1
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
|
Injury, poisoning and procedural complications
Sternal Fracture
|
0.00%
0/13
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
6.7%
1/15 • Number of events 1
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's Lymphoma
|
0.00%
0/13
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
6.7%
1/15 • Number of events 1
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
Other adverse events
| Measure |
Precision Spinal Cord Stimulator
n=13 participants at risk
Precision Spinal Cord Stimulation System
|
Back Surgery
n=15 participants at risk
Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.4%
2/13 • Number of events 2
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
0.00%
0/15
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/13
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
6.7%
1/15 • Number of events 1
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
7.7%
1/13 • Number of events 1
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
0.00%
0/15
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • Number of events 1
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
0.00%
0/15
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • Number of events 1
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
6.7%
1/15 • Number of events 1
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
|
Nervous system disorders
Neuralgia
|
7.7%
1/13 • Number of events 1
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
6.7%
1/15 • Number of events 1
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
|
General disorders
Implant site haematoma
|
7.7%
1/13 • Number of events 1
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
0.00%
0/15
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
|
General disorders
Implant site pain
|
7.7%
1/13 • Number of events 1
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
0.00%
0/15
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
7.7%
1/13 • Number of events 1
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
0.00%
0/15
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
|
Injury, poisoning and procedural complications
Incision site pruritis
|
7.7%
1/13 • Number of events 1
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
0.00%
0/15
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
1/13 • Number of events 1
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
6.7%
1/15 • Number of events 1
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
6.7%
1/15 • Number of events 1
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/13
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
6.7%
1/15 • Number of events 1
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/13
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
6.7%
1/15 • Number of events 1
The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place