Evaluating the Nevro1 System for Treating Sacroiliac Joint Dysfunction
A Post-market, Multicenter, Prospective, Clinical Study to Evaluate the Nevro1 Sacroiliac (SI) Transfixing and Fusion System for the Treatment of Sacroiliac Joint Dysfunction
This study is testing a new device to see if it can help adults with sacroiliac joint pain feel better and improve their condition over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Nevro Corp Industry-sponsored |
| Locations | 5 sites (Lodi, California and 4 other locations) |
| Trial ID | NCT06909292 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of the Nevro1 Sacroiliac Transfixing and Fusion System in treating sacroiliac joint dysfunction in adults. It will measure the percentage of patients experiencing significant pain relief without adverse events, as well as the rate of successful fusion of the sacroiliac joint at one and two years post-procedure. Participants must have a history of low back or buttock pain that has not responded adequately to non-surgical treatments. The study will involve monitoring outcomes over an extended period to determine long-term benefits.
Who should consider this trial
Good fit: Ideal candidates are adults over 21 with chronic low back or buttock pain due to sacroiliac joint dysfunction that has not improved with non-surgical care.
Not a fit: Patients who have not undergone a trial of therapeutic intra-articular SIJ injection or those with conditions not related to sacroiliac joint dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant pain relief and improved quality of life for patients suffering from sacroiliac joint dysfunction.
How similar studies have performed: Previous studies on sacroiliac joint fusion techniques have shown promising results, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Has medical insurance that covers this standard of care procedure and all other anticipated and unanticipated procedure-related care, and all coverage criteria required by insurer are met, which may include but are not limited to: * Has had low back and/or buttock pain for at least 6 months that is inadequately responsive to non-surgical care * Has a positive Fortin's test * Has a diagnosis of SIJ dysfunction (degenerative sacroiliitis or SI disruption) with pain elicited on at least 3 of 5 provocative tests (FABER, Gaenslen, Distraction, Thigh Thrust, Compression). * At least 75% reduction in pain for the expected duration of two anesthetics (on separate visits each with a different duration of action), and the ability to perform previously painful maneuvers, following an image-guided, contrast-enhanced intra-articular (diagnostic) SIJ injection * A trial of at least one therapeutic intra-articular SIJ injection (i.e. corticosteroid injection) 2. Has an ODI score ≥30% at enrollment 3. Has a SI joint pain score of at least 5 out of 10 on numerical rating scale at enrollment. 4. Be at least 21 years of age at enrollment 5. The patient's physician has decided that the best treatment for the patient's SIJ dysfunction is the Nevro1 SI Fixation System, and the patient has agreed to the treatment 6. Be willing and capable of giving written informed consent 7. Be mentally and physically able to comply with study-related requirements and procedures and attend all scheduled visits Exclusion Criteria: 1. Has current severe back pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, lumbar radicular pain, and lumbar vertebral body fracture 2. Has SIJ pain secondary to inflammatory conditions or other known sacroiliac pathology such as: Sacral dysplasia, inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondylo-arthropathy), tumor, infection, acute fracture, and crystal arthropathy 3. Has had a previous SIJ implant placement, including an allograft 4. Has had an injection with corticosteroid into the index SIJ within the last 30 days 5. Has had a sacral radiofrequency ablation within the last 6 months 6. Has a history of recent (\<1 year) major trauma to pelvis 7. Has previously diagnosed or suspected severe osteoporosis (defined as prior T-score \< -2.5 or history of osteoporotic fracture) 8. Has a chronic rheumatologic condition (e.g., rheumatoid arthritis) 9. Has a known allergy to titanium or titanium alloys 10. Has a current local or systemic infection that raises the risk of surgery 11. Is currently receiving or seeking short- or long-term worker's compensation related to the SI joint or low back pain, is currently receiving disability remuneration related to SI joint or low back pain, and/or is currently involved in injury litigation related to the SI joint or low back pain 12. Is participating in an investigational study or has been involved in an investigational study within 3 months prior to enrollment 13. Has any condition or anatomy that makes treatment with the Nevro1 SI Fixation System infeasible 14. Is taking a medication known to have detrimental effects on bone quality and soft tissue healing 15. Has a prominent neurologic condition that would interfere with physical therapy 16. Be pregnant or plan on becoming pregnant in the next two years. 17. Has a medical condition or pain in other area(s), not intended to be treated in this study, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
Where this trial is running
Lodi, California and 4 other locations
- AIRS Clinic — Lodi, California, United States (Recruiting)
- Michigan Orthopaedic Surgeons — Southfield, Michigan, United States (Not_yet_recruiting)
- Carolinas Pain Institute — Winston-Salem, North Carolina, United States (Recruiting)
- Advanced Spine and Pain Specialists — Spring, Texas, United States (Recruiting)
- Procura Pain and Spine — The Woodlands, Texas, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.