Investigating Superion™ In Spinal Stenosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lumbar Spinal Stenosis, Intermittent Claudication

Intervention / Treatment
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* Device: Superion™ Interspinous Spacer
* Device: X-STOP® IPD® Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Interspinous Process Spacer Device | Device: Superion™ Interspinous Spacer<br>* Implantation of interspinous process spacer to treat lumbar spinal stenosis<br>|
| Active Comparator: 2<br>Interspinous Process Spacer Device | Device: X-STOP® IPD® Device<br>* Implantation of interspinous process spacer to treat lumbar spinal stenosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Clinically Significant Improvement in Outcomes | 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 | Baseline and 24 months |