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REFINE Study: A Study In a Novel Interspinous Fusion Device In Subjects With Low Back Pain
Sponsor: Pacific Research Institute
Summary
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.
Official title: REFINE Study: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2021-03-19
Completion Date
2028-01-01
Last Updated
2022-08-18
Healthy Volunteers
Yes
Conditions
Interventions
Interspinous Fusion
The intended study population are adults 18 years or older with symptomatic lumbar degenerative disc disease resulting in back pain with lower extremity symptoms and neurogenic claudication that improves with spinal flexion who are candidates for use of the Zip™ MIS Interspinous Fusion device when undergoing spinal fixation procedures.
Locations (10)
Evolve Restorative Center
Santa Rosa, California, United States
The Raso Pain Center
Jupiter, Florida, United States
Koga Neurosurgery
Slidell, Louisiana, United States
National Spine and Pain Centers
Oxon Hill, Maryland, United States
Comprehensive & Interventional Pain Management
Henderson, Nevada, United States
Nevada Advanced Pain Specialists
Reno, Nevada, United States
Reno Tahoe Pain Associates
Reno, Nevada, United States
The Pain Management Center
Voorhees Township, New Jersey, United States
Premier Pain Treatment Institute
Loveland, Ohio, United States
Center for Interventional Pain and Spine
Chadds Ford, Pennsylvania, United States