Sacroiliac (SI) Joint Transfixing and Fusion: Meaningful Long Term Outcomes With Nevro1 (NCT06909292) | Clinical Trial Compass
RecruitingNot Applicable
Sacroiliac (SI) Joint Transfixing and Fusion: Meaningful Long Term Outcomes With Nevro1
United States180 participantsStarted 2025-04-03
Plain-language 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.
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. 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 an ODI score ≥30% at enrollment
✓. Has a SI joint pain score of at least 5 out of 10 on numerical rating scale at enrollment.
✓. Be at least 21 years of age at enrollment
✓. 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
✓. Be willing and capable of giving written informed consent
✓. Be mentally and physically able to comply with study-related requirements and procedures and attend all scheduled visits
Exclusion criteria
✕. 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
✕. 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
✕. Has had a previous SIJ implant placement, including an allograft