REFINE Study: A Study In a Novel Interspinous Fusion Device In Subjects With Low Back Pain

Part of paid clinical trials in Santa Rosa, California.

Sponsor
Pacific Research Institute
Study ID
NCT05504499
Status
Recruiting
Apply to this trial

Conditions

  • Lumbar Spinal Stenosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Interspinous Fusion — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Mar 19, 2021
Status verified
Aug 2022
Primary completion
Jan 1, 2028
Completion
Jan 1, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    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

Primary Outcome Measure

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 [ Time Frame: 12 months ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Evolve Restorative CenterSanta RosaCalifornia95403-
The Raso Pain CenterJupiterFlorida33477
Jodie Laprade
[email protected]
561-264-2929
Louis Raso, MD (PRINCIPAL_INVESTIGATOR)
Koga NeurosurgerySlidellLouisiana70458
Rachel Englert, RN
[email protected]
985-269-7676
Sebastian Koga, MD (PRINCIPAL_INVESTIGATOR)
National Spine and Pain CentersOxon HillMaryland20745
Diamond Wilson
[email protected]
301-485-7400
Vipul Mangal, MD (PRINCIPAL_INVESTIGATOR)
Comprehensive & Interventional Pain ManagementHendersonNevada89509
Shepard Urban
[email protected]
702-990-4530
Rainer Vogel, MD (PRINCIPAL_INVESTIGATOR)
Nevada Advanced Pain SpecialistsRenoNevada20745
Rachel Yetter
[email protected]
775-284-8650
Denis Patterson, DO (PRINCIPAL_INVESTIGATOR)
Reno Tahoe Pain AssociatesRenoNevada89509
Maria Peregrina
[email protected]
775-236-8596
Ali Nairizi, MD (PRINCIPAL_INVESTIGATOR)
The Pain Management CenterVoorhees TownshipNew Jersey08043
Onoshoze Bossey
[email protected]
609-382-0392
Youseff Josephson, MD (PRINCIPAL_INVESTIGATOR)
Premier Pain Treatment InstituteLovelandOhio45140
Kathy White
[email protected]
513-454-7246
Michael Danko, MD (PRINCIPAL_INVESTIGATOR)
Center for Interventional Pain and SpineChadds FordPennsylvania17601
Ashley Scherer
[email protected]
844-365-7246
Ashley K
[email protected]
844.365.7246
Steven Falowski, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Santa Rosa, CA

By research site
Evolve Restorative Center· Santa Rosa, CAThe Raso Pain Center· Jupiter, FLKoga Neurosurgery· Slidell, LANational Spine and Pain Centers· Oxon Hill, MDComprehensive & Interventional Pain Management· Henderson, NVNevada Advanced Pain Specialists· Reno, NV

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