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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00692276
Other study ID # 08-VISS-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2008
Est. completion date February 2017

Study information

Verified date November 2020
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The proposed prospective, multi-center, randomized clinical trial is designed to evaluate the safety and effectiveness of the Superion™ ISS compared to the X-STOP® IPD® device in healthy adults suffering from at least 6 months of moderate spinal stenosis symptoms who have been unresponsive to conservative care.


Description:

The proposed prospective, multi-center, randomized clinical trial is designed to evaluate the safety and effectiveness of the Superion™ ISS compared to the X-STOP® IPD® device in healthy adults suffering from at least 6 months of moderate spinal stenosis symptoms who have been unresponsive to conservative care. The study endpoint is the rate of overall subject success at 24 months.


Recruitment information / eligibility

Status Completed
Enrollment 391
Est. completion date February 2017
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender All
Age group 45 Years and older
Eligibility Inclusion Criteria: - Male or female subjects = 45 years of age - 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: - Axial back pain only - 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

Study Design


Intervention

Device:
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

Locations

Country Name City State
United States University of Colorado Hospital- The Spine Center- Anshutz Outpatient Pavilion Aurora Colorado
United States Greater Baltimore Neurosurgical Associates at GBMA Baltimore Maryland
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 The Center for Pain Relief, Inc Charleston West Virginia
United States Rush University Medical Center Chicago Illinois
United States New England Center for Clinical Research Cranston Rhode Island
United States Florida Research Associates, LLC DeLand Florida
United States Durango Orthopedic Associates, P.C./Spine Colorado Durango Colorado
United States Triangle Orthopaedic Associates Durham North Carolina
United States NeuroSpine Institute, LLC Eugene Oregon
United States Shrock Orthopedic Research Fort Lauderdale Florida
United States East Tennessee Brain & Spine Center Johnson City Tennessee
United States Orange County Neurosurgical Associates Laguna Hills California
United States Colorado Spine And Scoliosis Institute Littleton Colorado
United States Brain and Spine Research Institute Los Angeles California
United States Institute for Low Back and Neck Care Minneapolis Minnesota
United States Yale University New Haven Connecticut
United States Pacific Pain Medicine Consultants/Pacific Surgery Center Oceanside California
United States Sports Medicine North Peabody Massachusetts
United States Orthopedics Associates of the Greater Lehigh Valley Phillipsburg New Jersey
United States Arizona Center for Neurosurgery Phoenix Arizona
United States Texas Back Institute Plano Texas
United States Performance Spine and Sports Physicians Pottstown Pennsylvania
United States Spine Care and Rehabilitation, Inc. Roseland New Jersey
United States Orthopedics International Spine Seattle Washington
United States Spine Institute of Louisiana Shreveport Louisiana
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 Tucson Orthopaedic Institute Tucson Arizona
United States The George Washington Universtiy Medical Facility Washington District of Columbia
United States OrthopaediCare (Abington Orthopaedic Specialists) Willow Grove Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Boston Scientific Corporation VertiFlex, Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Subjects With Clinically Significant Improvement in Outcomes Where clinically significant improvement in outcomes compared to baseline, as determined by meeting the following:
At least two of three domains of the Zurich Claudication Questionnaire (ZCQ) [validated, condition-specific patient-reported questionnaire that captures data in three distinct domains]
Improvement in physical function by =0.5 points
Improvement in symptom severity by =0.5 points
"Satisfied" or "somewhat satisfied" as defined by a score of = 2.5 points on the patient satisfaction domain
No re-operations, revisions, removals or supplemental fixation at the index level(s)
No major implant- or procedure-related complications:
No dislodgement, migration, or deformation
No new or persistent worsened neurological deficit at the index level
No spinous process fractures
No deep infection, death, or other permanent device attributed disability
No clinically significant confounding treatments:
No epidural injections or nerve block proc
Baseline and 24 months
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