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

Description

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

Lumbar Spinal Stenosis

Study Overview

Study Details

Study overview

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.

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

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

Condition
Lumbar Spinal Stenosis
Intervention / Treatment

-

Contacts and Locations

Santa Rosa

Evolve Restorative Center, Santa Rosa, California, United States, 95403

Jupiter

The Raso Pain Center, Jupiter, Florida, United States, 33477

Slidell

Koga Neurosurgery, Slidell, Louisiana, United States, 70458

Oxon Hill

National Spine and Pain Centers, Oxon Hill, Maryland, United States, 20745

Henderson

Comprehensive & Interventional Pain Management, Henderson, Nevada, United States, 89509

Reno

Nevada Advanced Pain Specialists, Reno, Nevada, United States, 20745

Reno

Reno Tahoe Pain Associates, Reno, Nevada, United States, 89509

Voorhees

The Pain Management Center, Voorhees, New Jersey, United States, 08043

Loveland

Premier Pain Treatment Institute, Loveland, Ohio, United States, 45140

Chadds Ford

Center for Interventional Pain and Spine, Chadds Ford, Pennsylvania, United States, 17601

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Subjects enrolled in this study must meet ALL of the following
  • * Subjects enrolled in this study must NOT meet any of the following

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Pacific Research Institute,

Study Record Dates

2028-01-01