A Post-market, Multicenter, Prospective, Clinical Study to Evaluate the Nevro1 Sacroiliac (SI) Transfixing and Fusion System for the Treatment of Sacroiliac Joint Dysfunction
Nevro Corp
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
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
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, Compres…
Interventions
- DeviceSacroiliac Joint transfixing and fusion system (Nevro1)
The Nevro1 is a titanium cage the is implanted in the sacroiliac join from a posterior direction, and then anchors are deployed that stabilize the joint. It has multiple openings to allow surgeons to fill them with autogenous bone graft to encourage bone bridging through the implant for SIJ fusion.
Locations (5)
- AIRS ClinicLodi, California
- Michigan Orthopaedic SurgeonsSouthfield, Michigan
- Carolinas Pain InstituteWinston-Salem, North Carolina
- Advanced Spine and Pain SpecialistsSpring, Texas
- Procura Pain and SpineThe Woodlands, Texas