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RECRUITING
NCT06909292

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

Sponsor: Nevro Corp

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

OBSERVATIONAL

Enrollment

180

Start Date

2025-04-03

Completion Date

2027-06

Last Updated

2025-04-04

Healthy Volunteers

No

Interventions

DEVICE

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.

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