Interspinous Fusion for Lumbar Spinal Stenosis

Phase-Based Progress Estimates
Premier Pain Treatment Institute, Loveland, OHLumbar Spinal StenosisInterspinous Fusion - Device
All Sexes
What conditions do you have?

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.

Eligible Conditions
  • Lumbar Spinal Stenosis

Treatment Effectiveness

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 12 months

12 months
Complication Rate
Imaging analysis
To characterize patient global impression of change (PGIC) relative to baseline at 3 and 12 months.
To evaluate the efficacy and safety of the Aurora Spine ZIP™ MIS Interspinous Fusion System and bone graft material based on improvement in composite endpoints relative to baseline at 3 and 12 months 1. > 20mm pain reduction in VAS Back while standing
• To demonstrate real-world evidence of a significant improvement in the Pain Impact Score using ZIP™ as measured by the PROMIS-29 relative to baseline at 3 and 12 months.
• To identify patterns related to the influence of pharmacologic agents on response to therapy (and vice versa).

Trial Safety

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

Single Arm
Experimental Group · 1 Intervention: Interspinous Fusion · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

Pacific Research InstituteLead Sponsor
1 Previous Clinical Trials
100 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You experience relief from lower back bending or sitting.
You have moderate to severe back and/or leg pain while standing or walking, rated at 50mm or higher on a visual scale.

Who else is applying?

What state do they live in?
How old are they?
What site did they apply to?
Koga Neurosurgery50.0%
Premier Pain Treatment Institute50.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
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?

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

Unverified Answer

Are there any open spots for volunteers in this research endeavor?

"Affirmative, the evidence on 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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.