Sacroiliac (SI) Joint Transfixing and Fusion: Meaningful Long Term Outcomes With Nevro1
NCT ID: NCT06909292
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
180 participants
OBSERVATIONAL
2025-04-03
2027-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Post-Market Clinical Study on a Modular SI Joint Fusion System
NCT05916092
Clinical Outcome and Fusion Results Using the SiJoin® Transfixing Sacroiliac Fusion Device
NCT05712850
Sacroiliac Joint Fusion Comparison Study
NCT03230279
Treatment of Sacroiliac Dysfunction With SI-LOK® Sacroiliac Joint Fixation SI-SI-LOK
NCT01861899
Real-World Registry Study on Patient Satisfaction With TransLoc 3D SI Joint Fusion
NCT06487936
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treated Group
Treated with Nevro1 transfixing and fusion system
Sacroiliac 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sacroiliac 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 score ≥30% at enrollment
3. Has a SI joint pain score of at least 5 out of 10 on numerical rating scale at enrollment.
4. Be at least 21 years of age at enrollment
5. 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
6. Be willing and capable of giving written informed consent
7. Be mentally and physically able to comply with study-related requirements and procedures and attend all scheduled visits
Exclusion Criteria
2. 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
3. Has had a previous SIJ implant placement, including an allograft
4. Has had an injection with corticosteroid into the index SIJ within the last 30 days
5. Has had a sacral radiofrequency ablation within the last 6 months
6. Has a history of recent (\<1 year) major trauma to pelvis
7. Has previously diagnosed or suspected severe osteoporosis (defined as prior T-score \< -2.5 or history of osteoporotic fracture)
8. Has a chronic rheumatologic condition (e.g., rheumatoid arthritis)
9. Has a known allergy to titanium or titanium alloys
10. Has a current local or systemic infection that raises the risk of surgery
11. Is currently receiving or seeking short- or long-term worker's compensation related to the SI joint or low back pain, is currently receiving disability remuneration related to SI joint or low back pain, and/or is currently involved in injury litigation related to the SI joint or low back pain
12. Is participating in an investigational study or has been involved in an investigational study within 3 months prior to enrollment
13. Has any condition or anatomy that makes treatment with the Nevro1 SI Fixation System infeasible
14. Is taking a medication known to have detrimental effects on bone quality and soft tissue healing
15. Has a prominent neurologic condition that would interfere with physical therapy
16. Be pregnant or plan on becoming pregnant in the next two years.
17. Has a medical condition or pain in other area(s), not intended to be treated in this study, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nevro Corp
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rose P Azalde, MS
Role: STUDY_DIRECTOR
Nevro Corp
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
AIRS Clinic
Lodi, California, United States
Michigan Orthopaedic Surgeons
Southfield, Michigan, United States
Carolinas Pain Institute
Winston-Salem, North Carolina, United States
Advanced Spine and Pain Specialists
Spring, Texas, United States
Procura Pain and Spine
The Woodlands, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CA2024-02 US SIJ-PM
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.