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iO-Flex® System Decompression for Spondylolisthesis (STRiDE Trial)
N/A
Waitlist Available
Led By Sylvain Palmer, M.D.
Research Sponsored by Baxano Surgical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ODI score of 30/100 or greater
Adult (> 18 years of age)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6, 12, 24, 36, 48 and 60 months
Awards & highlights
STRiDE Trial Summary
This trial is to see if a new treatment for spinal stenosis and degenerative lumbar spondylolisthesis works better than the current standard of care, which has a 55% success rate.
Who is the study for?
This trial is for adults over 18 with leg or buttock pain due to spinal stenosis and a confirmed grade I degenerative lumbar spondylolisthesis. Participants must have tried non-surgical treatments for at least 6 months without success, have an ODI score of at least 30/100, and an NRS leg pain score of at least 4/10. They should be able to consent and complete questionnaires.Check my eligibility
What is being tested?
The study tests the iO-Flex® System's effectiveness in decompressing the spine for patients with spinal stenosis and stable grade I spondylolisthesis. It assumes a positive response rate of 55% based on precision estimates.See study design
What are the potential side effects?
While specific side effects are not listed, typical risks may include discomfort at the site of surgery, infection risk post-operation, potential nerve damage during decompression, bleeding, or blood clots.
STRiDE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My back pain affects my daily life significantly.
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I am over 18 years old.
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I have a mild case of one vertebra slipping over another.
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My leg pain is at least a 4 out of 10.
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My condition did not improve after 6 months of non-surgical treatment.
Select...
I have been diagnosed with lumbar spinal stenosis.
STRiDE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6, 12, 24, 36, 48 and 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6, 12, 24, 36, 48 and 60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Numerical Rating Scale (NRS)
Operative success
Oswestry Disability Index (ODI)
+3 moreSTRiDE Trial Design
1Treatment groups
Experimental Treatment
Group I: SurgeryExperimental Treatment1 Intervention
Decompression using the iO-Flex® system
Find a Location
Who is running the clinical trial?
Baxano Surgical, Inc.Lead Sponsor
5 Previous Clinical Trials
569 Total Patients Enrolled
3 Trials studying Spondylolisthesis
460 Patients Enrolled for Spondylolisthesis
Sylvain Palmer, M.D.Principal InvestigatorNeurological Surgery Medical Associates
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have cauda equina syndrome.I have a bone condition like Paget's disease affecting my spine.My back pain affects my daily life significantly.I only have back pain.I have a fracture in one of my lower back vertebrae.I have had surgery on my lower back.My surgery may involve removing central spine structures but will try to preserve certain ligaments.My lower back is very unstable, moving more than 4mm.My spine condition is more severe than a mild slip.I am unwilling to receive a blood transfusion if needed.I am over 18 years old.I have pain in my leg or buttock, with or without back pain.I have a mild case of one vertebra slipping over another.My leg pain is at least a 4 out of 10.I have been diagnosed with lumbar spinal stenosis.My lower back curve is 25 degrees or more.I cannot communicate clearly in English.My diabetes is not under control.I do not have a bleeding disorder that cannot be managed.I have been diagnosed with severe nerve pain in my limbs by a specialist.I do not have an infection at the time of surgery.I have a tumor in my spine or another type of cancer, not including basal cell carcinoma.My BMI is over 40.I have confirmed spinal stenosis in the L2-S1 region with matching symptoms.My condition did not improve after 6 months of non-surgical treatment.My surgery isn't mainly for disc problems, but disc removal might happen.I experience leg pain when walking due to poor blood flow.I have had fractures in my spine due to weak bones.
Research Study Groups:
This trial has the following groups:- Group 1: Surgery
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Spondylolisthesis Patient Testimony for trial: Trial Name: NCT01338766 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings for individuals to join this clinical trial?
"The information displayed on clinicaltrials.gov reveals that this particular medical trial is no longer enrolling patients. Although launched in April 2011 and last updated three years ago, 128 other studies are still accepting participants at the moment."
Answered by AI
How many sites within the state are executing this clinical trial?
"Resurgens Orthopaedics in Cumming, Georgia, Scott and White Memorial Hospital in Temple, Texas, University California Irvine in Orange, California are three of the 15 clinical sites participating this trial. The other 12 locations can be found online."
Answered by AI
Who else is applying?
What state do they live in?
Virginia
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have tried everything. PT on a regular basis..working out every week. Lots of medications and I have had years and years of pain. Nothing has worked and I would love some relief so I can enjoy my life. I want to travel and it is painful now. So please let me be part of the trail. Thank you! Patricia Woodson.
PatientReceived 1 prior treatment
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