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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 391
- Locations
- 64
- Primary Endpoint
- Percentage of Subjects With Clinically Significant Improvement in Outcomes
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Secondary Outcomes
No secondary outcomes reported