SI Joint Stabilization in Long Fusion to the Pelvis (SILVIA)

  • STATUS
    Not Recruiting
  • End date
    Dec 11, 2024
  • participants needed
    220
  • sponsor
    SI-BONE, Inc.
Updated on 20 July 2022

Summary

The purpose of this study is to compare outcomes of subjects undergoing multilevel lumbar fusion (MLF) surgery with and without the iFuse 3-D implants in the "bedrock" trajectory.

Description

This is a multicenter randomized controlled, postmarket clinical study to determine the differences between subjects undergoing standard MLF surgery with S2AI fixation in the pelvis vs the additional placement of iFuse 3-D in the bedrock configuration during MLF surgery. Subjects will be monitored for sacroiliac (SI) joint pain and at two years post surgery a CT scan will be taken to assess S2AI screw loosening or any other findings.

Details
Condition Sacroiliac Joint Disruption, Scoliosis Lumbar Region
Treatment iFuse 3-D in Bedrock Configuration, Multilevel Lumbar Fusion surgery
Clinical Study IdentifierNCT04062630
SponsorSI-BONE, Inc.
Last Modified on20 July 2022

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