Actively Recruiting
REFINE Study: A Study In a Novel Interspinous Fusion Device In Subjects With Low Back Pain
Led by Pacific Research Institute · Updated on 2022-08-18
100
Participants Needed
10
Research Sites
354 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the effectiveness and safety of the use of Aurora Spine ZIP™ MIS Interspinous Fusion System and bone graft material in fusion in patients with chronic low back pain that present with degenerative disc disease with concurrent neurogenic claudication.
CONDITIONS
Official Title
REFINE Study: A Study In a Novel Interspinous Fusion Device In Subjects With Low Back Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent before any study procedures
- Be 18 years or older and skeletally mature
- Have 1-2 symptomatic lumbar degenerative disease levels from T12 to S1, with or without grade I spondylolisthesis confirmed by history and imaging
- Have an MRI within 12 months showing mild to moderate spinal stenosis at the treatment level
- Have tried non-operative treatment for at least 3 months
- Have a Zurich Claudication Questionnaire physical function score of 2.0 or higher at baseline
- Experience relief of symptoms with lumbar flexion or sitting
- Have baseline back and/or leg pain of 50mm or greater on the Visual Analog Scale while standing or walking
You will not qualify if you...
- Unable to provide written informed consent
- Previous lumbar spine surgery at the intended treatment level (such as laminectomy or fusion)
- Grade II or higher spondylolisthesis with 3mm or more instability on flexion and extension X-rays
- Confirmed or suspected osteoporosis or osteopenia
- Currently enrolled in or planning to participate in another investigational drug or device study that could affect results
- Any other medical, social, psychological, or anatomical conditions that might limit participation or follow-up compliance
- Pregnant or nursing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Evolve Restorative Center
Santa Rosa, California, United States, 95403
Active, Not Recruiting
2
The Raso Pain Center
Jupiter, Florida, United States, 33477
Actively Recruiting
3
Koga Neurosurgery
Slidell, Louisiana, United States, 70458
Actively Recruiting
4
National Spine and Pain Centers
Oxon Hill, Maryland, United States, 20745
Actively Recruiting
5
Comprehensive & Interventional Pain Management
Henderson, Nevada, United States, 89509
Actively Recruiting
6
Nevada Advanced Pain Specialists
Reno, Nevada, United States, 20745
Actively Recruiting
7
Reno Tahoe Pain Associates
Reno, Nevada, United States, 89509
Actively Recruiting
8
The Pain Management Center
Voorhees Township, New Jersey, United States, 08043
Actively Recruiting
9
Premier Pain Treatment Institute
Loveland, Ohio, United States, 45140
Actively Recruiting
10
Center for Interventional Pain and Spine
Chadds Ford, Pennsylvania, United States, 17601
Actively Recruiting
Research Team
S
Shelley Trimm, BS
CONTACT
K
Kam Murrell
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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