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Spinal Stabilization Device

LimiFlex vs Fusion Surgery for Spinal Stenosis

N/A
Waitlist Available
Led By William C Welch, MD
Research Sponsored by Empirical Spine, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be aged between 25-80 years and skeletally mature
Patients must be candidates for surgical decompression at one or two contiguous levels, with stabilization at one level between L1-S1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial will compare the safety and effectiveness of two different surgeries for lumbar degenerative spondylolisthesis with spinal stenosis. One surgery uses a device called the LimiFlex™ Paraspinous Tension Band, while the other is a transforaminal lumbar interbody fusion with posterolateral fusion (TLIF/PLF).

Who is the study for?
Adults aged 25-80 with Grade I degenerative spondylolisthesis and lumbar spinal stenosis, experiencing leg pain or weakness after at least 3 months of non-surgical treatment. Candidates should have a certain level of disability and pain as measured by ODI and VAS scales, suitable anatomy for the device post-decompression, and be able to consent to study requirements.Check my eligibility
What is being tested?
The trial is testing the LimiFlex Paraspinous Tension Band's safety and effectiveness against traditional fusion surgery (TLIF/PLF) following decompression in patients with lumbar spinal stenosis caused by spondylolisthesis. Participants are enrolled into either the LimiFlex or TLIF/PLF group at different sites.See study design
What are the potential side effects?
Potential side effects may include complications from surgical procedures such as infection, bleeding, nerve damage, or issues related to the devices used like breakage or slippage. Specific side effects will depend on whether participants receive the LimiFlex device or undergo fusion surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 25 and 80 years old and my bones have stopped growing.
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I am a candidate for spine surgery between the L1 and S1 vertebrae.
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I have a slipped disc in my lower back, confirmed by an X-ray.
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I need surgery for spinal narrowing at 1 or 2 levels between L1 and S1.
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My symptoms have not improved after 3 months of basic treatment.
Select...
My back pain severely limits my daily activities.
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My spine's structure is suitable for a specific type of spinal surgery.
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I experience leg pain from nerve issues in my spine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite Clinical Success
Secondary outcome measures
Absence of device integrity failures defined as device breakage, device separation or disassembly, or device dislocation
Additional surgical interventions
Estimated blood loss
+13 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: LimiFlexExperimental Treatment2 Interventions
Posterior dynamic stabilization with the LimiFlex Paraspinous Tension Band
Group II: FusionActive Control3 Interventions
Transforaminal lumbar interbody fusion with concomitant posterolateral fusion with pedicle screw instrumentation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Decompression
2021
N/A
~1040

Find a Location

Who is running the clinical trial?

Biomedical Statistical ConsultingUNKNOWN
Medical Metrics Diagnostics, IncIndustry Sponsor
12 Previous Clinical Trials
1,390 Total Patients Enrolled
MCRAIndustry Sponsor
29 Previous Clinical Trials
8,841 Total Patients Enrolled

Media Library

Lumbar Spinal Stenosis Research Study Groups: Fusion, LimiFlex

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to join in this clinical experiment?

"For eligibility, prospective participants must have a diagnosis of spinal stenosis and be between 25 and 80 years old. The trial organisers plan to enrol 315 people in total."

Answered by AI

Are fresh participants being accepted into this research endeavor?

"According to clinicaltrials.gov, this trial is not presently open for recruitment as the last update was posted on May 3rd 2022. Nonetheless, there are 272 other studies actively recruiting patients at present."

Answered by AI

Does the trial permit senior citizens to participate?

"This trial is seeking applicants between the ages of 25 and 80. Those who are younger than 18 or older than 65 can consider one of the 23 studies which cater to minors, or 265 trials for seniors respectively."

Answered by AI

In what areas is this clinical experiment currently taking place?

"For this clinical trial, UC Davis Spine Center in Sacramento, Missouri and Washington University School of Medicine in Saint Louis are two participating sites. Additionally, Texas Back Institue Clinical Research LLC-Plano locations is also involved with 28 other medical centres across the US."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
Missouri
Illinois
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Kaiser Permanente Division of Research
UC Davis Spine Center
Other
Washington University School of Medicine
How many prior treatments have patients received?
3+

What questions have other patients asked about this trial?

When does this study start?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

I’m so sick of being in pain. I need to work and it is becoming unbearable.
PatientReceived 1 prior treatment
I have had the chronic conditions addressed by this study for several decades. PT, chiropractic, meds, epidurals, stem cell and other approaches have all yielded only limited results.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
LimiFlex Clinical Trial for the Treatment of Degenerative Spondylolisthesis With Spinal Stenosis
2017. "LimiFlex Clinical Trial for the Treatment of Degenerative Spondylolisthesis With Spinal Stenosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03115983.
~41 spots leftby Apr 2025
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