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Investigating Superion™ In Spinal Stenosis [ISISS]

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
VertiFlex, Incorporated
ClinicalTrials.gov Identifier:
NCT00692276
First received: June 4, 2008
Last updated: November 27, 2012
Last verified: November 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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:

MedlinePlus related topics: Spinal Stenosis
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Oswestry Disability Index [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: June 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00692276

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

No publications provided by VertiFlex, Incorporated

Additional 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
Study First Received: June 4, 2008
Last Updated: November 27, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 22, 2013