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Spondylolisthesis Treated With an iO-Flex® System Enabled Decompression | Clinical Trials | Clareo Health

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Spondylolisthesis Treated With an iO-Flex® System Enabled Decompression

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

NCT01338766•Baxano Surgical, Inc.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Adult (\> 18 years of age)
•2. Leg/buttock pain, with or without back pain
•3. Grade 1 degenerative spondylolisthesis (≤25% slippage)
•4. NRS pain score for leg pain of 4/10 or greater
•5. ODI score of 30/100 or greater
•6. Failed non-operative medical management for a period of at least 6 months
•7. Confirmed clinical diagnosis of lumbar spinal stenosis
•8. Confirmation of central and/or lateral recess stenosis with or without foraminal stenosis, at one level or at two adjacent levels from L2-S1, with concordant symptoms. Subjects with central and/or lateral recess stenosis and spondylolisthesis at one level, may have symptomatic central, lateral recess or foraminal stenosis treated at one adjacent level. A "below-the pedicle" pass to decompress a third segment can be completed provided laminotomies are performed at no more than 2 levels. Subjects that, following an intraoperative decision, have a 3-level laminotomy and decompression will not be considered enrolled. Confirmation of spinal stenosis is shown on MRI or CT scan with evidence of nerve root impingement (displacement or compression) by either osseous or non-osseous elements.
•9. Ability to give voluntary, written informed consent to participate in this clinical investigation and ability to participate in follow up examinations and complete patient questionnaires

Exclusion Criteria

•1. Back pain only
•2. Diagnosis of moderate to severe peripheral neuropathy such as diabetic or idiopathic peripheral neuropathy, by EMG/NCS or a Neurologist.
•3. History of pathologic fractures of the vertebrae
•4. Primary disc pathology; planned or incidental discectomies will NOT be excluded as long as surgeon believes the disc pathology is not the primary reason for the surgical intervention.
•5. Subjects for whom removal of the midline structures is planned, likely or is the result of an intraoperative decision; every attempt should be made to spare the supraspinous, interspinous and facet capsular ligaments.
•6. Significant instability of the lumbar spine as defined by ≥ 4mm translational motion between standing lateral view flexion and extension radiographs
•7. Prior surgery of the lumbar spine
•8. Spondylolisthesis greater than grade 1 (on a scale of 1 to 4)
•9. Spondylolysis (pars fracture) at any level in the lumbar spine
•10. Degenerative lumbar scoliosis with a Cobb angle of ≥ 25°
+17 more criteria

Locations (14)

Eden Medical Center

Castro Valley, California, United States

Olympia Medical Center

Los Angeles, California, United States

Orange County Neurological Associates

Mission Viejo, California, United States

University California Irvine

Orange, California, United States

Southern California Orthopedic Institute

Van Nuys, California, United States

Georgetown University

Washington D.C., District of Columbia, United States

Medical Center of Trinity

Odessa, Florida, United States

Florida Orthopaedic Institute

Temple Terrace, Florida, United States

Resurgens Orthopaedics

Cumming, Georgia, United States

Suburban Orthopedics

Bartlett, Illinois, United States

Key Dates

Start Date

April 1, 2011

Primary Completion Date

December 1, 2014

Last Updated

April 23, 2014

Enrollment

100

ESTIMATED participants

Conditions

RadiculopathySpondylolisthesisLumbar Spinal Stenosis

Interventions

Decompression using the iO-Flex® system

PROCEDURE

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Lumbar Spinal Stenosis

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RECRUITINGPHASE4

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Lumbar Spinal StenosisLumbar Disc Herniation+8 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 23, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Spondylolisthesis Treated With an iO-Flex® System Enabled Decompression

Inclusion Criteria

Exclusion Criteria

Study Comparing Local/ MAC Anesthesia in Lumbar Decompression

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