Sacroiliac (SI) Joint Transfixing and Fusion: Meaningful Long Term Outcomes With Nevro1

NCT06909292 | Recruiting FDA Device

• 1 other identifier: CA2024-02 US SIJ-PM
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Sacroiliac Joint Dysfunction

Keywords

Sacroiliac transfixing; sacroiliac fusion; sacroiliac joint pain

Outcome Measures

Primary Outcomes (1)

• Composite 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.

  6 months

Secondary Outcomes (6)

• Change in Disability

  6 months

• Patient Global Impression of Change (PGIC)

  6 months

• Physical and Mental Health Summary (PROMIS-29)

  6 months

• Change in Quality of Life

  6 months

• Change in Sleep Disturbance Due to Pain

  6 months

Other Outcomes (6)

• Presence of bone apposition on implant surface

  12 and 24 months

• Presence of bony fusion across the sacroiliac joint

  12 and 24 months

• Presence of radiolucency at the implant surface

  12 and 24 months

Study Arms (1)

Treated Group

Treated with Nevro1 transfixing and fusion system

Device: Sacroiliac Joint transfixing and fusion system (Nevro1)

Interventions

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.

Treated Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cohort will be selected from participating clinics

You may qualify if:

• 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, 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)
• 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

You may not qualify if:

• 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
• Has had an injection with corticosteroid into the index SIJ within the last 30 days
• Has had a sacral radiofrequency ablation within the last 6 months
• Has a history of recent (\<1 year) major trauma to pelvis
• Has previously diagnosed or suspected severe osteoporosis (defined as prior T-score \< -2.5 or history of osteoporotic fracture)
• Has a chronic rheumatologic condition (e.g., rheumatoid arthritis)
• Has a known allergy to titanium or titanium alloys
• Has a current local or systemic infection that raises the risk of surgery
• 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
• Is participating in an investigational study or has been involved in an investigational study within 3 months prior to enrollment
• Has any condition or anatomy that makes treatment with the Nevro1 SI Fixation System infeasible
• Is taking a medication known to have detrimental effects on bone quality and soft tissue healing
• Has a prominent neurologic condition that would interfere with physical therapy

Sponsors & Collaborators

• Nevro Corp: lead

Study Sites (5)

AIRS Clinic

Lodi, California, 95240, United States

RECRUITING

Michigan Orthopaedic Surgeons

Southfield, Michigan, 48033, United States

NOT YET RECRUITING

Carolinas Pain Institute

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Advanced Spine and Pain Specialists

Spring, Texas, 77380, United States

RECRUITING

Procura Pain and Spine

The Woodlands, Texas, 77384, United States

RECRUITING

Study Officials

• Rose P Azalde, MS

  Nevro Corp

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start: April 3, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)