Study Summary
This trial will study whether the Aurora Spine ZIP MIS Interspinous Fusion System is an effective and safe treatment for patients with chronic low back pain and degenerative disc disease who also have neurogenic claudication.
- Lumbar Spinal Stenosis
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 5 Secondary · Reporting Duration: 12 months
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Single Arm
1 of 1
Experimental Treatment
100 Total Participants · 1 Treatment Group
Primary Treatment: Interspinous Fusion · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Louisiana | 50.0% |
| Ohio | 50.0% |
How old are they?
| 65+ | 100.0% |
What site did they apply to?
| Koga Neurosurgery | 50.0% |
| Premier Pain Treatment Institute | 50.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
Why did patients apply to this trial?
- "I am in some much pain. I cannot function. Please help."
How many prior treatments have patients received?
| 1 | 100.0% |
- Falowski SM, Raso LJ, Mangal V, Narizi A, Patterson DG, Danko MD, Justiz R, Vogel RS, Koga S, Josephson Y, Pope JE. A Prospective, Observational, Open-Label, Non-Randomized, Multicenter Study Measuring Functional Outcomes in a Novel Interspinous Fusion Device in Subjects with Low Back Pain: REFINE Study. Pain Ther. 2022 Oct 20. doi: 10.1007/s40122-022-00447-0. [Epub ahead of print]
- Falowski SM, Raso LJ, Mangal V, Narizi A, Patterson DG, Danko MD, Justiz R, Vogel RS, Koga S, Josephson Y, Pope JE. A Prospective, Observational, Open-Label, Non-Randomized, Multicenter Study Measuring Functional Outcomes in a Novel Interspinous Fusion Device in Subjects with Low Back Pain: REFINE Study. Pain Ther. 2022 Oct 20. doi: 10.1007/s40122-022-00447-0. Online ahead of print.
- Falowski SM, Raso LJ, Mangal V, Narizi A, Patterson DG, Danko MD, Justiz R, Vogel RS, Koga S, Josephson Y, Pope JE. A Prospective, Observational, Open-Label, Non-Randomized, Multicenter Study Measuring Functional Outcomes in a Novel Interspinous Fusion Device in Subjects with Low Back Pain: REFINE Study. Pain Ther. 2023 Feb;12(1):187-199. doi: 10.1007/s40122-022-00447-0. Epub 2022 Oct 20.
- 2021. "REFINE Study: A Study In a Novel Interspinous Fusion Device In Subjects With Low Back Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05504499.
Frequently Asked Questions
To what extent is this clinical trial being implemented in medical establishments throughout the United States?
"At present, this medical experiment is recruiting from 9 sites located in Reno, Jupiter and Slidell among other cities. To limit travel requirements for potential participants it would be ideal to select the closest clinical trial location." - Anonymous Online Contributor
Are there any open spots for volunteers in this research endeavor?
"Affirmative, the evidence on clinicaltrials.gov indicates that recruitment is ongoing for this trial, which was initially posted on March 19th 2021 and most recently edited August 16th 2022. 100 individuals need to be enrolled from 9 distinct medical facilities." - Anonymous Online Contributor
What is the current number of participants enrolled in this trial?
"This medical trial necessitates the recruitment of 100 qualified patients. Qualifying individuals can participate at Nevada Advanced Pain Specialists in Reno and The Raso Pain Center in Jupiter, Florida." - Anonymous Online Contributor