Study Results
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View full resultsBasic Information
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COMPLETED
NA
391 participants
INTERVENTIONAL
2008-06-30
2017-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
Interspinous Process Spacer Device
Superion™ Interspinous Spacer
Implantation of interspinous process spacer to treat lumbar spinal stenosis
2
Interspinous Process Spacer Device
X-STOP® IPD® Device
Implantation of interspinous process spacer to treat lumbar spinal stenosis
Interventions
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Superion™ Interspinous Spacer
Implantation of interspinous process spacer to treat lumbar spinal stenosis
X-STOP® IPD® Device
Implantation of interspinous process spacer to treat lumbar spinal stenosis
Eligibility Criteria
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Inclusion Criteria
* Persistent leg/buttock/groin pain, with or without back pain, that is relieved by flexion activities (example: sitting or bending over a shopping cart)
* Diagnosis of degenerative spinal stenosis of the lumbar spine, defined as the narrowing of the midline sagittal spinal canal (central) and/or narrowing between the facet superior articulating process (SAP), the posterior vertebral margin (lateral recess), and the nerve root canal (foraminal)
* Must be able to sit for 50 minutes without pain and to walk 50 feet or more
Exclusion Criteria
* Fixed motor deficit
* Diagnosis of lumbar spinal stenosis which requires any direct neural decompression or surgical intervention other than those required to implant the control or experimental device
* Unremitting pain in any spinal position
* Significant peripheral neuropathy or acute denervation secondary to radiculopathy
* Lumbar spinal stenosis at more than two levels determined pre-operatively to require surgical intervention
* Significant instability of the lumbar spine as defined by 3mm translation or 5 degrees angulation
* Sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and/or hips
* Spondylolisthesis or degenerative spondylolisthesis greater than grade 1.0 (on a scale of 1 to 4)
* Spondylolysis (pars fracture)
* Morbid obesity, defined as Body Mass Index (BMI) greater than 40kg/m2
* Insulin-dependent diabetes mellitus
* Prior surgery of the lumbar spine
* Cauda equina syndrome (defined as neural compression causing neurogenic bowel or bladder dysfunction)
* Infection in the disc or spine, past or present
* Paget's disease at involved segment or metastasis to the vertebra, osteomalacia, or other metabolic bone disease
* Tumor in the spine or a malignant tumor except for basal cell carcinoma
* Involved in pending litigation of the spine or worker's compensation related to the back
45 Years
ALL
No
Sponsors
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VertiFlex, Incorporated
INDUSTRY
Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Roshini Jain
Role: STUDY_DIRECTOR
Boston Scientific Corporation
Locations
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Arizona Center for Neurosurgery
Phoenix, Arizona, United States
Tucson Orthopaedic Institute
Tucson, Arizona, United States
D.I.S.C. Sports and Spine Center
Beverly Hills, California, United States
Tower Orthopaedics and Sports Medicine/ Institute for Advanced Spinal Research
Beverly Hills, California, United States
Orange County Neurosurgical Associates
Laguna Hills, California, United States
Brain and Spine Research Institute
Los Angeles, California, United States
Pacific Pain Medicine Consultants/Pacific Surgery Center
Oceanside, California, United States
University of Colorado Hospital- The Spine Center- Anshutz Outpatient Pavilion
Aurora, Colorado, United States
Durango Orthopedic Associates, P.C./Spine Colorado
Durango, Colorado, United States
Colorado Spine And Scoliosis Institute
Littleton, Colorado, United States
Yale University
New Haven, Connecticut, United States
The George Washington Universtiy Medical Facility
Washington D.C., District of Columbia, United States
Florida Research Associates, LLC
DeLand, Florida, United States
Shrock Orthopedic Research
Fort Lauderdale, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Spine Institute of Louisiana
Shreveport, Louisiana, United States
Greater Baltimore Neurosurgical Associates at GBMA
Baltimore, Maryland, United States
Sports Medicine North
Peabody, Massachusetts, United States
Institute for Low Back and Neck Care
Minneapolis, Minnesota, United States
Orthopedics Associates of the Greater Lehigh Valley
Phillipsburg, New Jersey, United States
Spine Care and Rehabilitation, Inc.
Roseland, New Jersey, United States
Stony Brook University Medical Center, Dept. of Neurological Surgery
Stony Brook, New York, United States
Upstate Medical Universtiy-Department of Orthopedics- Institute for Spine Care
Syracuse, New York, United States
Triangle Orthopaedic Associates
Durham, North Carolina, United States
NeuroSpine Institute, LLC
Eugene, Oregon, United States
Performance Spine and Sports Physicians
Pottstown, Pennsylvania, United States
OrthopaediCare (Abington Orthopaedic Specialists)
Willow Grove, Pennsylvania, United States
New England Center for Clinical Research
Cranston, Rhode Island, United States
East Tennessee Brain & Spine Center
Johnson City, Tennessee, United States
Texas Back Institute
Plano, Texas, United States
Orthopedics International Spine
Seattle, Washington, United States
The Center for Pain Relief, Inc
Charleston, West Virginia, United States
Countries
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References
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Patel VV, Whang PG, Haley TR, Bradley WD, Nunley PD, Miller LE, Block JE, Geisler FH. Two-year clinical outcomes of a multicenter randomized controlled trial comparing two interspinous spacers for treatment of moderate lumbar spinal stenosis. BMC Musculoskelet Disord. 2014 Jul 5;15:221. doi: 10.1186/1471-2474-15-221.
Loguidice V, Bini W, Shabat S, Miller LE, Block JE. Rationale, design and clinical performance of the Superion(R) Interspinous Spacer: a minimally invasive implant for treatment of lumbar spinal stenosis. Expert Rev Med Devices. 2011 Jul;8(4):419-26. doi: 10.1586/erd.11.24.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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08-VISS-01
Identifier Type: -
Identifier Source: org_study_id