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

NCT06909292 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2025-04-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Nevro Corp

    lead INDUSTRY

Principal Investigators

  • Rose P Azalde, MS · Nevro Corp

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-03
Primary Completion
2027-03-31
Completion
2027-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06909292 on ClinicalTrials.gov