Lumbar Spinal Stenosis Clinical Trial
Official title:
Spondylolisthesis Treated With an iO-Flex® System Enabled Decompression (STRiDE)
The purpose of this study is to evaluate the clinical performance of a decompression using the FDA cleared iO-Flex® System on-label in treating patients with spinal stenosis and stable grade I degenerative lumbar spondylolisthesis using a precision estimate assuming a 55% positive response rate.
This is a prospective, non-randomized, multi-center (up to 30 sites) controlled clinical
study enrolling 100 subjects following a pre-specified protocol with no site enrolling more
than 30 subjects. All eligible subjects providing written informed consent and meeting study
eligibility criteria will receive a facet preserving decompression using the FDA cleared
iO-Flex® system on label. Treatment success using the iO-Flex® System will be analyzed using
a precision estimate assuming a 55% positive response rate.
In addition to baseline characteristics and procedural parameters, subject outcomes will be
assessed at 6 weeks, 6-, 12-, and 24 months. The study will have an extended follow-up phase
with annual follow-up contact through 5 years to evaluate retreatment for the original
indication at these late time points.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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