RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2021-03-19
Study Completion:2028-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05504499

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects enrolled in this study must meet ALL of the following
  1. * Subjects enrolled in this study must NOT meet any of the following

Contacts and Locations

Study Contact

Shelley Trimm, BS
CONTACT
7075085527
strimm@pacificresearchinstitute.care
Kam Murrell
CONTACT
267.818.9024
kmurrell@pacificresearchinstitute.care

Study Locations (Sites)

Evolve Restorative Center
Santa Rosa, California, 95403
United States
The Raso Pain Center
Jupiter, Florida, 33477
United States
Koga Neurosurgery
Slidell, Louisiana, 70458
United States
National Spine and Pain Centers
Oxon Hill, Maryland, 20745
United States
Comprehensive & Interventional Pain Management
Henderson, Nevada, 89509
United States
Nevada Advanced Pain Specialists
Reno, Nevada, 20745
United States
Reno Tahoe Pain Associates
Reno, Nevada, 89509
United States
The Pain Management Center
Voorhees, New Jersey, 08043
United States
Premier Pain Treatment Institute
Loveland, Ohio, 45140
United States
Center for Interventional Pain and Spine
Chadds Ford, Pennsylvania, 17601
United States

Collaborators and Investigators

Sponsor: Pacific Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-19
Study Completion Date2028-01-01

Study Record Updates

Study Start Date2021-03-19
Study Completion Date2028-01-01

Terms related to this study

Additional Relevant MeSH Terms

  • Lumbar Spinal Stenosis