Sacroiliac (SI) Joint Transfixing and Fusion: Meaningful Long Term Outcomes With Nevro1

Recruiting

• Conditions: Sacroiliac Joint Dysfunction

• Registration Number: NCT06909292
• Lead Sponsor: Nevro Corp

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-27
• Study First Submitted QC: 2025-03-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Study Start: 2025-04-03
• Study First Posted: 2025-04-03
• Last Update Posted: 2025-04-04
• Primary Completion: 2027-03
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite Pain Relief and Safety Responder	6 months	The proportion of patient meeting the following criteria: * NRS score for SIJ pain reduced by at least 2 points from baseline.; * Absence of implant-related serious adverse events (SAEs).; * Absence of neurologic worsening related to the lumbosacral nerve roots.; * Absence of reoperation (removal, revision reoperation or supplemental fixation) for SIJ pain.

Secondary Outcome Measures

Name	Time	Method
Change in Disability	6 months	Absolute change from baseline in Oswestry Disability Index (ODI) score. The total score ranges from 0 (minimal disability) to 100 (severe disability, e.g., bedridden).
Patient Global Impression of Change (PGIC)	6 months	Proportion of patients reporting "Better" or "A great deal better" on the PGIC. The PGIC is a 7-point scale with responses ranging from "no change (or condition has gotten worse)" to "a great deal better".
Physical and Mental Health Summary (PROMIS-29)	6 months	Absolute change from baseline in PROMIS-29 score. Higher scores represent greater impact of pain on a patients life in the domains of physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance.
Change in Quality of Life	6 months	Absolute change from baseline in the index score of EuroQol 5-dimension 5 level (EQ-5D-5L) a standardized measure of health status. The index score ranges from zero to one, with one representing the highest possible health state.
Change in Sleep Disturbance Due to Pain	6 months	Absolute change from baseline in Pain and Sleep Questionnaire Three-Item Index (PSQ-3) score. The scale ranges from 0 (pain does not affect sleep) to 30 (pain has maximum effect on sleep).
Timed "Up and Go" Performance test (TUG)	6 months	Absolute change from baseline in time to perform the TUG.

Trial Locations

Locations (5)

AIRS Clinic; 🇺🇸 Lodi, California, United States

Michigan Orthopaedic Surgeons; 🇺🇸 Southfield, Michigan, United States

Carolinas Pain Institute; 🇺🇸 Winston-Salem, North Carolina, United States

Advanced Spine and Pain Specialists; 🇺🇸 Spring, Texas, United States

Procura Pain and Spine; 🇺🇸 The Woodlands, Texas, United States