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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated Group | Treated with Nevro1 transfixing and fusion system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacroiliac Joint transfixing and fusion system (Nevro1) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Pain Relief and Safety Responder | The proportion of patient meeting the following criteria:
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 months |
| Patient Global Impression of Change (PGIC) |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of bone apposition on implant surface | Grading of the presence of bone apposition on the device adjacent to the sacrum and ilium. | 12 and 24 months |
| Presence of bony fusion across the sacroiliac joint |
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:
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Cohort will be selected from participating clinics
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| Name | Affiliation | Role |
|---|---|---|
| Rose P Azalde, MS | Nevro Corp | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AIRS Clinic | Lodi | California | 95240 | United States | ||
| Michigan Orthopaedic Surgeons |
Study data will be reported with descriptive statistics describing group level outcomes, not individual outcomes.
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|
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".
| 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. | 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. | 6 months |
| Change in Sleep Disturbance Due to Pain | 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). | 6 months |
| Timed "Up and Go" Performance test (TUG) | Absolute change from baseline in time to perform the TUG. | 6 months |
Grading of the presence of bony fusion across the sacroiliac joint.
| 12 and 24 months |
| Presence of radiolucency at the implant surface | Grading of the presence of radiolucency at the device surface adjacent to the sacrum and ilium. | 12 and 24 months |
| Proportion of patients with different levels of treatment response | Evaluating different pain relief response rates, defining responder as a participant who experiences ≥30%, ≥50% and ≥80% pain relief vs. Baseline as measured by NRS. | 3, 6, 12, and 24 months |
| Sub-analysis comparing outcomes between age groups | All outcomes will be compared between the two age groups: 21 to 70 years, and 71 years and above. | 3, 6, 12, and 24 months. |
| Rate of adverse events | Proportion of patients who experience and adverse event related to the procedure or device including infection, device breakage, migration, neurological worsening, and procedural blood loss. | Implant, 1, 3, 6, 12, and 24 months. |
| Southfield |
| Michigan |
| 48033 |
| United States |
| Carolinas Pain Institute | Winston-Salem | North Carolina | 27103 | United States |
| Advanced Spine and Pain Specialists | Spring | Texas | 77380 | United States |
| Procura Pain and Spine | The Woodlands | Texas | 77384 | United States |