NCT01338766

Spondylolisthesis Treated With an iO-Flex® System Enabled Decompression

Spondylolisthesis Treated With an iO-Flex® System Enabled Decompression (STRiDE)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Baxano Surgical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Radiculopathy
• Spondylolisthesis
• Lumbar Spinal Stenosis

Interventions

Type	Name	Description
PROCEDURE	Decompression using the iO-Flex® system	Decompression using the iO-Flex® system

Timeline

• Start date: 2011-04-01
• Primary completion: 2014-12-01
• First posted: 2011-04-20
• Last updated: 2014-04-23

Locations

14 sites across 1 country: United States