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Trial record 1 of 1 for:    investigating superion in spinal stenosis
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Investigating Superion™ In Spinal Stenosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00692276
Recruitment Status : Completed
First Posted : June 6, 2008
Results First Posted : August 25, 2020
Last Update Posted : November 16, 2020
Sponsor:
Collaborator:
VertiFlex, Incorporated
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Lumbar Spinal Stenosis Intermittent Claudication Device: Superion™ Interspinous Spacer Device: X-STOP® IPD® Device Not Applicable

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 391 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Center, Randomized Study Comparing the VertiFlex® Superion™ Interspinous Spacer (ISS) to the X-STOP® Interspinous Process Decompression (IPD®) System in Patients With Moderate Lumbar Spinal Stenosis
Study Start Date : June 2008
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Interspinous Process Spacer Device
 Device: Superion™ Interspinous Spacer
Implantation of interspinous process spacer to treat lumbar spinal stenosis
Active Comparator: 2
Interspinous Process Spacer Device
 Device: X-STOP® IPD® Device
Implantation of interspinous process spacer to treat lumbar spinal stenosis


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Subjects With Clinically Significant Improvement in Outcomes [ Time Frame: Baseline and 24 months ]

    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


Eligibility Criteria
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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00692276


Locations
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Sponsors and Collaborators
Boston Scientific Corporation
VertiFlex, Incorporated
Investigators
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Study Director: Roshini Jain Boston Scientific Corporation
  Study Documents (Full-Text)

Documents provided by Boston Scientific Corporation:
Study Protocol and Statistical Analysis Plan  [PDF] June 19, 2015

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00692276    
Other Study ID Numbers: 08-VISS-01
First Posted: June 6, 2008    Key Record Dates
Results First Posted: August 25, 2020
Last Update Posted: November 16, 2020
Last Verified: November 2020
Additional relevant MeSH terms:
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Spinal Stenosis
Constriction, Pathologic
Spinal Diseases
Intermittent Claudication
Pathological Conditions, Anatomical
Bone Diseases
 Musculoskeletal Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases