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.
Study Type
OBSERVATIONAL
Enrollment
180
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.
AIRS Clinic
Lodi, California, United States
RECRUITINGMichigan Orthopaedic Surgeons
Southfield, Michigan, United States
NOT_YET_RECRUITINGCarolinas Pain Institute
Winston-Salem, North Carolina, United States
RECRUITINGComposite Pain Relief and Safety Responder
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.
Time frame: 6 months
Change in Disability
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).
Time frame: 6 months
Patient Global Impression of Change (PGIC)
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".
Time frame: 6 months
Physical and Mental Health Summary (PROMIS-29)
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.
Time frame: 6 months
Change in Quality of Life
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.
Time frame: 6 months
Change in Sleep Disturbance Due to Pain
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Advanced Spine and Pain Specialists
Spring, Texas, United States
RECRUITINGProcura Pain and Spine
The Woodlands, Texas, United States
RECRUITINGAbsolute 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).
Time frame: 6 months
Timed "Up and Go" Performance test (TUG)
Absolute change from baseline in time to perform the TUG.
Time frame: 6 months