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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Lumbar Spinal Stenosis
- Sponsor
- Boston Scientific Corporation
- Enrollment
- 391
- Locations
- 32
- Primary Endpoint
- Percentage of Subjects With Clinically Significant Improvement in Outcomes
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
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.
Investigators
Eligibility 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)
Outcomes
Primary Outcomes
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