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RECRUITING
NCT05504499
NA

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

Sponsor: Pacific Research Institute

View on ClinicalTrials.gov

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

Interventions

DEVICE

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