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 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
391
Implantation of interspinous process spacer to treat lumbar spinal stenosis
Implantation of interspinous process spacer to treat lumbar spinal stenosis
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
Time frame: Baseline and 24 months
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