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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Decompression using the iO-Flex® system
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
Oswestry Disability Index (ODI)
Responder analysis
Time frame: 24 Months
Operative success
Achieving intended decompression using the iO-Flex® System. The number of neural foramen in which the iO-Flex® System was used for decompression compared to the number in which an attempt was made but not completed.
Time frame: Operative (day 1)
Oswestry Disability Index (ODI)
Responder analysis
Time frame: 6, 12, 36, 48 and 60 months
Oswestry Disability Index (ODI)
Comparison of ODI scores between baseline and each of the following follow-up visits: 6, 12, 24, 36, 48, and 60 month visits
Time frame: 6, 12, 24, 36, 48 and 60 months
Numerical Rating Scale (NRS)
Comparison of NRS scores for back and leg pain between baseline and each of the following follow-up visits: 6, 12, 24, 36, 48, and 60 month visits
Time frame: 6, 12, 24, 36, 48 and 60 months
Zurich Claudication Questionnaire (ZCQ)
Comparison of ZCQ scores between baseline and each of the following follow-up visits: 6, 12, 24, 36, 48, and 60 month visits
Time frame: 6, 12, 24, 36, 48 and 60 months
SF-36 Health Survey
Comparison of SF-36 scores between baseline and each of the following follow-up visits: 6, 12, 24, 36, 48, and 60 month visits
Time frame: 6, 12, 24, 36, 48 and 60 months
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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
...and 4 more locations
Treatment survival rate
To characterize longevity of the treatment effect of a decompression using the iO-Flex® System.
Time frame: Ongoing out to 60 months