Spinal Cord Stimulation With Precision® System Versus Reoperation for Failed Back Surgery Syndrome
NCT ID: NCT01036529
Last Updated: 2020-11-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE4
28 participants
INTERVENTIONAL
2010-02-28
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Precision Spinal Cord Stimulator
Spinal Cord Stimulation
Precision Spinal Cord Stimulator
Programming settings will be specific to the individual needs in accordance with the labeling
Back Surgery
Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation
Back Surgery
Different types of back surgery may be performed
Interventions
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Precision Spinal Cord Stimulator
Programming settings will be specific to the individual needs in accordance with the labeling
Back Surgery
Different types of back surgery may be performed
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Significant complaint of persistent or recurrent radicular leg pain, with or without low back pain
* One or more prior lumbosacral surgical procedures (no upper limit)
* At least 6 months duration of persistent or recurrent radicular leg pain, with or without low back pain
* Study candidates meet the criteria for a specific surgical intervention as recorded by a surgeon: pain refractory to conservative care, with concordant neurologic, tension, and/or mechanical signs and imaging findings of surgically remediable neural compression
* MRI or CT myelogram of the lumbar and thoracic spine (within 12 months prior to screening) that rules out pathology that might compromise SCS electrode placement or pathology, in addition to neural compression, that might contribute to the subject's pain
* All study candidates must pass study site's routine psychological/psychiatric evaluation for SCS before randomization to SCS or reoperation
* At least 18 years of age
* Subject signs informed consent
Exclusion Criteria
* Pain intensity of always 10 on a 0-10 Numerical Rating Scale over the past 6 months based on subject recall
* Radiographic evidence of frank instability (grossly mobile spondylolisthesis or abnormal subluxation) requiring fusion, calcific arachnoiditis, or severe thoracic stenosis
* Radiographically demonstrated (by myelographic block or its MRI equivalent) critical cauda equinal compression
* A disabling or potentially disabling neurologic deficit (e.g., foot drop, neurogenic bladder) in the distribution of a nerve root or roots caused by surgically remediable compression
* A predominance of non-organic signs on physical exam
* A concurrent clinically significant or disabling chronic pain problem or condition that is likely to confound evaluation of study endpoints (e.g., chronic migraine, significant arthrosis of the hip associated with groin pain as primary complaint)
* Significant substance abuse issues
* Major untreated psychiatric comorbidity
* Unresolved issues of secondary gain (e.g., litigation)
* Expected inability to report treatment outcome adequately
* Expected inability to operate SCS system
* Pregnancy (actual or planned)
* Life expectancy less than 3 years due to other serious medical condition(s)
* Active local or systemic infection
* Prior SCS procedure
* Presence of intrathecal drug pump
* Participation in another clinical study that would confound data of this study
* Occupational risk that would rule out SCS
* Medical or cardiac condition(s) or therapies, or foreseeable need for therapies or diagnostic tests (e.g., MRI), that preclude SCS and/or reoperation
18 Years
ALL
Yes
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Richard North, M.D.
Role: PRINCIPAL_INVESTIGATOR
The Sandra and Malcolm Berman Brain & Spine Institute
Locations
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Scripps Clinic
La Jolla, California, United States
University of California San Diego
La Jolla, California, United States
Orthopedic Research Foundation
Savannah, Georgia, United States
Millenium Pain Center
Bloomington, Illinois, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
The University of Illinois Medical Center
Chicago, Illinois, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
St. Patrick Hospital
Missoula, Montana, United States
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Swedish Neuroscience Institute
Seattle, Washington, United States
Pacific Medical Center
Seattle, Washington, United States
Hopital de Enfant-Jesus
Québec, Quebec, Canada
Regina General Hospital
Regina, Saskatchewan, Canada
CHU de Nantes-Hopital Laennec
Nantes, , France
Frenchay Hospital
Bristol, , United Kingdom
James Cook University Hospital
Middlesbrough, , United Kingdom
Countries
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Other Identifiers
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A2005
Identifier Type: -
Identifier Source: org_study_id