Interspinous Fusion for Lower Back Pain
(Refine Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinator or your doctor.
What data supports the effectiveness of the treatment Aurora Spine ZIP™ MIS Interspinous Fusion System for lower back pain?
Research on interspinous spacers, like the Aurora ZIP system, shows they can effectively relieve pressure on the spine and improve stability, which may help with lower back pain. Studies on similar devices have shown positive results in maintaining spinal movement and reducing stress on the spine.12345
Is the Aurora Spine ZIP™ MIS Interspinous Fusion System safe for humans?
The safety of interspinous devices, like the Aurora Spine ZIP™ MIS Interspinous Fusion System, has been studied in various contexts. Research shows that these devices are generally safe, providing stability to the spine and maintaining similar pressure levels in the spine as before surgery, with minimal increase in motion after repeated use.26789
How is the Aurora Spine ZIP™ MIS Interspinous Fusion System treatment different from other treatments for lower back pain?
Eligibility Criteria
This trial is for adults over 18 with chronic low back pain due to degenerative disc disease and mild to moderate spinal stenosis, who've tried non-surgical treatments for at least 3 months. Candidates should find relief in lumbar flexion/sitting and have significant pain while standing or walking. Exclusions include previous surgery at the treatment level, severe spondylolisthesis, osteoporosis, participation in other trials that could affect results, and pregnancy.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Aurora Spine ZIP™ MIS Interspinous Fusion System and bone graft material for single-level fusion
Follow-up
Participants are monitored for safety and effectiveness after treatment, including pain reduction and functional outcomes
Treatment Details
Interventions
- Aurora Spine ZIP™ MIS Interspinous Fusion System
Aurora Spine ZIP™ MIS Interspinous Fusion System is already approved in United States for the following indications:
- Degenerative disc disease
- Spinal stenosis
- Spondylolisthesis
- Trauma (fracture or dislocation)
- Tumor
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pacific Research Institute
Lead Sponsor