MIS SI Joint fusion using a lateral transfixing procedure

Early outcomes from the prospective, multicenter STACI study

Jacqueline Weisbein1, Jack Smith2, Timothy Davis3, Denis Patterson4, Douglas Beall5, Dan Nguyen5, Anne Christopher6, Daniel Kloster7, Andrew Trobridge8, John Hatheway9, John Broadnax10, Eric Anderson10, Caroline Harstroem11, Jeffrey Foster12, Charles Simmons13, Michael Harned14, Chris Mallard14

 

Introduction

Minimally invasive SIJ fusion using metallic implants via a lateral trans-iliac approach has shown significant outcome improvements. Initially performed by surgeons due to neurovascular risks, interventional pain management (IPM) physicians are now performing these fusions, though outcomes remain unpublished.

STACI (iFuse TORQ for the treatment of sacroiliac joint dysfunction) (NCT 05870488) is a prospective, multicenter study that will enroll 110 subjects across 15 Interventional Pain Management sites in the US and will follow them for 2 years. Herein we present an interim analysis of three-month outcomes.

 

Primary Endpoint: The change from baseline in SIJ pain on NRS at 6 months. 

Secondary Endpoints: Changes in pain, function, quality of life, device or procedure-related adverse events, and evidence of fusion as observed on a CT scan obtained at 2 years.