Actively Recruiting
Sacroiliac (SI) Joint Transfixing and Fusion: Meaningful Long Term Outcomes With Nevro1
Led by Nevro Corp · Updated on 2025-04-04
180
Participants Needed
5
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this observational study is to learn if Nevro1 Sacroiliac Transfixing and Fusion System can treat sacroiliac joint dysfunction in males or females over 21. The main questions it aims to answer is what percentage of patients have clinically important pain relief with no adverse events, and what proportion of patients have fusion of the sacroiliac joint at 1 year and 2 years.
CONDITIONS
Official Title
Sacroiliac (SI) Joint Transfixing and Fusion: Meaningful Long Term Outcomes With Nevro1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has medical insurance covering this procedure and related care, meeting all insurer criteria
- Has had low back and/or buttock pain for at least 6 months unresponsive to non-surgical care
- Has positive Fortin's test
- Diagnosed with sacroiliac joint dysfunction confirmed by at least 3 positive provocative tests
- At least 75% pain reduction from two diagnostic SI joint injections with anesthetics
- Has had at least one therapeutic SI joint injection
- Oswestry Disability Index score of 30% or higher at enrollment
- Sacroiliac joint pain score of 5 or greater on a 0-10 scale at enrollment
- At least 21 years of age at enrollment
- Physician has decided Nevro1 SI Fixation System is the best treatment and patient agrees
- Willing and able to give written informed consent
- Mentally and physically able to comply with study procedures and attend visits
You will not qualify if you...
- Has severe back pain from other causes like lumbar disc problems, spondylolisthesis, spinal stenosis, facet degeneration, radicular pain, or vertebral fractures
- Has sacroiliac pain due to inflammatory or other specific pathologies such as sacral dysplasia, ankylosing spondylitis, tumors, infections, fractures, or crystal arthropathy
- Has had a previous sacroiliac joint implant
- Received corticosteroid injection into the sacroiliac joint within the last 30 days
- Had sacral radiofrequency ablation within the past 6 months
- Experienced major pelvic trauma within the last year
- Diagnosed or suspected severe osteoporosis
- Has a chronic rheumatologic condition like rheumatoid arthritis
- Known allergy to titanium or its alloys
- Has current local or systemic infection increasing surgery risk
- Receiving or seeking worker's compensation or disability related to sacroiliac joint or low back pain, or involved in related litigation
- Participating or recently participated in another investigational study
- Has conditions or anatomy not suitable for Nevro1 treatment
- Taking medications harmful to bone or soft tissue healing
- Has neurological conditions interfering with physical therapy
- Pregnant or planning pregnancy within two years
- Has other medical conditions or pain that could interfere with study procedures or accurate pain reporting
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
AIRS Clinic
Lodi, California, United States, 95240
Actively Recruiting
2
Michigan Orthopaedic Surgeons
Southfield, Michigan, United States, 48033
Not Yet Recruiting
3
Carolinas Pain Institute
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
4
Advanced Spine and Pain Specialists
Spring, Texas, United States, 77380
Actively Recruiting
5
Procura Pain and Spine
The Woodlands, Texas, United States, 77384
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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