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Interspinous Fusion Device
Interspinous Fusion for Lower Back Pain (Refine Trial)
N/A
Recruiting
Research Sponsored by Pacific Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject has 1-2 symptomatic lumbar degenerative disease at adjacent level, T12-S1, with or without grade I spondylolisthesis (confirmed by history and radiographic studies).
Subject has baseline VAS of back and/or leg pain standing or walking ≥ 50mm.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Refine Trial Summary
This trial will study whether the Aurora Spine ZIP MIS Interspinous Fusion System is an effective and safe treatment for patients with chronic low back pain and degenerative disc disease who also have neurogenic claudication.
Who is the study for?
This trial is for adults over 18 with chronic low back pain due to degenerative disc disease and mild to moderate spinal stenosis, who've tried non-surgical treatments for at least 3 months. Candidates should find relief in lumbar flexion/sitting and have significant pain while standing or walking. Exclusions include previous surgery at the treatment level, severe spondylolisthesis, osteoporosis, participation in other trials that could affect results, and pregnancy.Check my eligibility
What is being tested?
The REFINE Study tests the Aurora Spine ZIP™ MIS Interspinous Fusion System with bone graft material on patients with lower back pain from spinal conditions. It aims to assess how effective and safe this fusion device is when treating chronic back pain associated with degenerative diseases of the spine.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks of interspinous fusion procedures can include infection, nerve damage leading to numbness or weakness, bleeding, persistent pain at the bone graft site or new onset of pain.
Refine Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have lower back issues due to degenerative disease in 1-2 spots from T12 to S1, with or without a slight spine misalignment.
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I experience significant back or leg pain when standing or walking.
Select...
My MRI shows I have mild to moderate spinal narrowing where I will be treated.
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I am 18 years or older and my bones have stopped growing.
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My back or leg pain when standing or walking is moderate to severe.
Select...
My MRI shows I have mild to moderate spinal stenosis.
Refine Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To evaluate the efficacy and safety of the Aurora Spine ZIP™ MIS Interspinous Fusion System and bone graft material based on improvement in composite endpoints relative to baseline at 3 and 12 months 1. > 20mm pain reduction in VAS Back while standing
Secondary outcome measures
Complication Rate
Imaging analysis
To characterize patient global impression of change (PGIC) relative to baseline at 3 and 12 months.
+2 moreRefine Trial Design
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
A Prospective, Open-Label, Non-Randomized, Multi-Center Study Measuring Functional Outcomes In a Novel Interspinous Fusion Device In Subjects With Low Back Pain A Prospective, Observational, Open-Label, Non-Randomized, Multi-Center Study Measuring Functional Outcomes In a Novel Interspinous Fusion Device In Subjects With Low Back Pain
Find a Location
Who is running the clinical trial?
Pacific Research InstituteLead Sponsor
1 Previous Clinical Trials
100 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with or suspected to have weak bones.Bending forward or sitting relieves my back pain.I have lower back issues due to degenerative disease in 1-2 spots from T12 to S1, with or without a slight spine misalignment.I experience significant back or leg pain when standing or walking.You have a physical function score of 2.0 or higher on the ZCQ test at the beginning of the study.My MRI shows I have mild to moderate spinal narrowing where I will be treated.I am 18 years or older and my bones have stopped growing.I feel less back pain when I bend forward or sit down.My back or leg pain when standing or walking is moderate to severe.My MRI shows I have mild to moderate spinal stenosis.I have been treated without surgery for at least 3 months.I am unable to sign a consent form.I have had surgery on my lower back at the same spot that needs treatment now.My spine condition shows a grade II or higher slippage with 3mm movement.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm
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.
Lumbar Spinal Stenosis Patient Testimony for trial: Trial Name: NCT05504499 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is this clinical trial being implemented in medical establishments throughout the United States?
"At present, this medical experiment is recruiting from 9 sites located in Reno, Jupiter and Slidell among other cities. To limit travel requirements for potential participants it would be ideal to select the closest clinical trial location."
Answered by AI
Are there any open spots for volunteers in this research endeavor?
"Affirmative, the evidence on clinicaltrials.gov indicates that recruitment is ongoing for this trial, which was initially posted on March 19th 2021 and most recently edited August 16th 2022. 100 individuals need to be enrolled from 9 distinct medical facilities."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
Other
New Jersey
Louisiana
How old are they?
65+
What site did they apply to?
Evolve Restorative Center
Koga Neurosurgery
The Pain Management Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
3+
Why did patients apply to this trial?
I am in some much pain. I cannot function. Please help. i have tried so many medications for pain nerve pain i have had at least 10 lumbar epidural injections nothing has worked.
PatientReceived 2+ prior treatments
I've had multiple injections done Including a couple of ablation procedures done as well as going to pain management and physical therapy doctors over the years that.
PatientReceived 2+ prior treatments
I've had multiple injections done Including a couple of ablation procedures done as well as going to pain management and physical therapy doctors over the years that have all failed.
PatientReceived no prior treatments
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