RecruitingNCT06909292

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

A Post-market, Multicenter, Prospective, Clinical Study to Evaluate the Nevro1 Sacroiliac (SI) Transfixing and Fusion System for the Treatment of Sacroiliac Joint Dysfunction


Sponsor

Nevro Corp

Enrollment

180 participants

Start Date

Apr 3, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Sacroiliac Joint transfixing and fusion system (Nevro1) for people with sacroiliac joint dysfunction. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 21 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESacroiliac 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.


Locations(5)

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

View Full Details on ClinicalTrials.gov

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NCT06909292


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