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Investigating Superion™ In Spinal Stenosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00692276
First Posted: June 6, 2008
Last Update Posted: June 7, 2017
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.
Information provided by (Responsible Party):
VertiFlex, Incorporated
  Purpose
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 Intervention
Lumbar Spinal Stenosis Intermittent Claudication Device: Superion™ Interspinous Spacer Device: X-STOP® IPD® Device

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by VertiFlex, Incorporated:

Primary Outcome Measures:
  • Effectiveness will be determined based on Zurich Claudication Questionnaire (ZCQ) results at 24 months relative to pre-treatment values [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • Oswestry Disability Index [ Time Frame: 24 months ]

Estimated Enrollment: 400
Study Start Date: June 2008
Study Completion Date: February 2017
Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
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
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


  Show 32 Study Locations
Sponsors and Collaborators
VertiFlex, Incorporated
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: VertiFlex, Incorporated
ClinicalTrials.gov Identifier: NCT00692276     History of Changes
Other Study ID Numbers: 08-VISS-01
First Submitted: June 4, 2008
First Posted: June 6, 2008
Last Update Posted: June 7, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Constriction, Pathologic
Spinal Stenosis
Intermittent Claudication
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms