NCT06909292 Sacroiliac (SI) Joint Transfixing and Fusion: Meaningful Long Term Outcomes With Nevro1
| NCT ID | NCT06909292 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nevro Corp |
| Condition | Sacroiliac Joint Dysfunction |
| Study Type | OBSERVATIONAL |
| Enrollment | 180 participants |
| Start Date | 2025-04-03 |
| Primary Completion | 2027-03 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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.
Eligibility 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 scor