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NCT05504499 · ClinicalTrials.gov registry record · NA
REFINE Study: A Study In a Novel Interspinous Fusion Device In Subjects With Low Back Pain
A NA study of Lumbar Spinal Stenosis, sponsored by Pacific Research Institute.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 10
- Study locations
NCT05504499: Recruiting NA study of Lumbar Spinal Stenosis, sponsored by Pacific Research Institute.
NCT05504499 is a NA study of Lumbar Spinal Stenosis that is actively recruiting participants, run by Pacific Research Institute. The registered enrollment target is 100 participants, below the 664-participant average among 18 other Lumbar Spinal Stenosis trials with a reported enrollment target (85% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05504499, a NA study of Lumbar Spinal Stenosis, is actively recruiting participants, sponsored by Pacific Research Institute.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 10
- Study locations
Study 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.
Primary Outcome
The primary composite endpoint is individual patient success from baseline at 3- and 12-months of follow-up, which will be assessed as follows: 1. \> 20mm pain reduction in VAS Back while standing or walking 2. \> 20mm pain reduction in VAS Leg while standing or walking 3. Zurich Claudication Questionnaire improvement of 0.5 or greater in 2 or 3 domains) 4. ODI improvement of ≥ 10pts 5. No reoperations or revisions at the index level (s)
Conditions Studied
Interventions
- DEVICE Interspinous Fusion
Study Locations (10)
Nevada
- Comprehensive & Interventional Pain Management - Henderson
- Nevada Advanced Pain Specialists - Reno
- Reno Tahoe Pain Associates - Reno
California
- Evolve Restorative Center - Santa Rosa
Florida
- The Raso Pain Center - Jupiter
Louisiana
- Koga Neurosurgery - Slidell
Maryland
- National Spine and Pain Centers - Oxon Hill
New Jersey
- The Pain Management Center - Voorhees Township
Ohio
- Premier Pain Treatment Institute - Loveland
Pennsylvania
- Center for Interventional Pain and Spine - Chadds Ford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-03-19 |
| Est. Completion | 2028-01-01 |
| Phase | NA |
What NCT05504499 shows while recruiting
NCT05504499 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 664-participant average among 18 other Lumbar Spinal Stenosis trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Lumbar Spinal Stenosis appearing as the primary indexed condition, and to 1 intervention - of which Interspinous Fusion is the first listed.
NCT05504499 lists 10 locations in 8 states (Nevada, California, Florida).
Frequently Asked Questions
What is clinical trial NCT05504499 about?
NCT05504499 is a clinical study titled "REFINE Study: A Study In a Novel Interspinous Fusion Device In Subjects With Low Back Pain". 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.
What is the current status of trial NCT05504499?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2021-03-19. Estimated completion is 2028-01-01.
What conditions does trial NCT05504499 study?
This clinical trial studies the following conditions: Lumbar Spinal Stenosis.
What interventions are being tested in trial NCT05504499?
The interventions under investigation include: Interspinous Fusion (DEVICE).
Who is sponsoring clinical trial NCT05504499?
This trial is sponsored by Pacific Research Institute, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05504499 being conducted?
This trial has 10 study locations across California, Florida, Louisiana, Maryland, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05504499's enrollment target sits among peer trials
100 10th of 18 higher than 6 of 18 other Lumbar Spinal Stenosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lumbar Spinal Stenosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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