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

Part of paid clinical trials in Lodi, California.

Sponsor
Nevro Corp
Study ID
NCT06909292
Status
Recruiting
Apply to this trial

Conditions

  • Sacroiliac Joint Dysfunction

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Apr 3, 2025
Status verified
Apr 2025
Primary completion
Mar 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
180 participants (estimated)

Arms

  • Arm: Treated Group
    Treated with Nevro1 transfixing and fusion system

Primary Outcome Measure

Composite Pain Relief and Safety Responder [ Time Frame: 6 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
AIRS ClinicLodiCalifornia95240
Ezell Askew, MD
[email protected]
209-224-5236
Ezell Askew, MD (PRINCIPAL_INVESTIGATOR)
Michigan Orthopaedic SurgeonsSouthfieldMichigan48033
Jad Khalil
[email protected]
248-663-1900
Jad Khalil, MD (PRINCIPAL_INVESTIGATOR)
Carolinas Pain InstituteWinston-SalemNorth Carolina27103
Leonardo Kapural, MD, PhD
[email protected]
336-765-6181
Leonardo Kapural, MD, PhD (PRINCIPAL_INVESTIGATOR)
Advanced Spine and Pain SpecialistsSpringTexas77380
Andrew Khoury, MD
[email protected]
281-868-7246
Andrew Khoury, MD (PRINCIPAL_INVESTIGATOR)
Procura Pain and SpineThe WoodlandsTexas77384
Thomas White, MD
[email protected]
713-352-0949
Thomas White, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Lodi, CA

By research site
AIRS Clinic· Lodi, CAMichigan Orthopaedic Surgeons· Southfield, MICarolinas Pain Institute· Winston-Salem, NCAdvanced Spine and Pain Specialists· Spring, TXProcura Pain and Spine· The Woodlands, TX

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