Actively Recruiting
A Post-market, Multicenter, Prospective Clinical Study to Evaluate the Nevro1 Sacroiliac Transfixing and Fusion System for Sacroiliac Joint Dysfunction
Led by Nevro Corp · Updated on 2025-04-04
180
Participants Needed
5
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Nevro1 Sacroiliac Transfixing and Fusion System in adults aged 21 and older who have sacroiliac joint dysfunction. This observational study aims to determine how many patients experience meaningful pain relief without adverse events and the rate of sacroiliac joint fusion at 1 and 2 years after treatment. The study is sponsored by Nevro Corp and focuses on long-term outcomes with this device. The Nevro1 device is a titanium cage implanted into the sacroiliac joint from the back, where anchors are deployed to stabilize the joint. The device has openings that allow surgeons to fill it with the patient's own bone graft to encourage fusion. Participants receive this treatment as part of their standard care, and the study observes the results over time without additional interventions. Participants will be monitored at scheduled visits where pain levels, disability, quality of life, sleep disturbance, and physical performance will be assessed using questionnaires and tests such as the Timed "Up and Go" test. The main outcome measured at 6 months is a combined evaluation of pain relief and safety. The study will also track changes in disability, overall health impression, mental and physical health, and quality of life. Total participation time varies by individual, with follow-ups planned up to at least two years to observe joint fusion and long-term effects.
CONDITIONS
Brief 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 standard care procedure and related care, meeting insurer requirements
- Has had low back and/or buttock pain for at least 6 months unresponsive to non-surgical treatment
- Has a positive Fortin's test
- Diagnosed with sacroiliac joint dysfunction confirmed by pain on at least 3 of 5 provocative tests
- Experienced at least 75% pain reduction from two diagnostic intra-articular SIJ injections
- Has had at least one therapeutic corticosteroid injection into the SIJ
- Has an Oswestry Disability Index score of 30% or higher at enrollment
- Has a sacroiliac joint pain score of 5 or more out of 10 at enrollment
- Is 21 years of age or older 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 requirements and attend visits
You will not qualify if you...
- Has severe back pain from other causes such as lumbar disc degeneration, herniation, spondylolisthesis, spinal stenosis, facet degeneration, radicular pain, or vertebral fracture
- Has sacroiliac joint pain due to inflammatory or other known sacroiliac conditions like sacral dysplasia, inflammatory sacroiliitis, tumor, infection, fracture, or crystal arthropathy
- Has had a previous sacroiliac joint implant including allograft
- Received corticosteroid injection into the SIJ within the last 30 days
- Had sacral radiofrequency ablation within the last 6 months
- History of major pelvic trauma within the past year
- Diagnosed or suspected severe osteoporosis
- Has a chronic rheumatologic condition such as rheumatoid arthritis
- Allergic to titanium or titanium alloys
- Has local or systemic infection increasing surgery risk
- Currently receiving or seeking worker's compensation, disability, or involved in injury litigation related to SI joint or low back pain
- Participating in another investigational study or was in one within 3 months prior
- Has conditions or anatomy making Nevro1 treatment not feasible
- Taking medications harmful to bone or soft tissue healing
- Has neurologic conditions interfering with physical therapy
- Pregnant or planning pregnancy in next two years
- Has medical conditions or pain elsewhere that could interfere with study procedures or accurate reporting as determined by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of implantation
Participants undergo implantation of the Nevro1 Sacroiliac Joint transfixing and fusion system, a device implanted to stabilize the sacroiliac joint and promote bone fusion.
1 visit (in-person)
Duration - 6 months
Participants are observed following implantation to assess pain relief, disability, quality of life, and physical function over six months.
Approximately 6 post-operative visits
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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