Safety and initial effectiveness of minimally invasive sacroiliac joint fusion with metal implants using a lateral transiliac approach: a prospective trial

Jacqueline Weisbein; Denis Patterson; Douglas Beall; Dan Nguyen; Jack Smith; Caroline Harstroem; Timothy Davis; Jeffrey Foster; Anne Christopher; Daniel Kloster; John Broadnax; Eric Anderson; John Hatheway; Andrew Trobridge; Charles Simmons; Thomas Stauss; Michael Harned; Christopher Mallard

doi:10.1093/pm/pnaf082

Safety and initial effectiveness of minimally invasive sacroiliac joint fusion with metal implants using a lateral transiliac approach: a prospective trial

Pain Med. 2025 Jun 26:pnaf082. doi: 10.1093/pm/pnaf082. Online ahead of print.

Authors

Jacqueline Weisbein¹, Denis Patterson², Douglas Beall³, Dan Nguyen³, Jack Smith⁴, Caroline Harstroem⁵, Timothy Davis⁶, Jeffrey Foster⁷, Anne Christopher⁸, Daniel Kloster⁹, John Broadnax¹⁰, Eric Anderson¹⁰, John Hatheway¹¹, Andrew Trobridge¹², Charles Simmons¹³, Thomas Stauss¹⁴, Michael Harned¹⁵, Christopher Mallard¹⁵

Affiliations

¹ Napa Valley Orthopaedics, Napa, CA, USA.
² Nevada Advanced Pain Specialists, Reno, NV, USA.
³ Clinical Investigations, LLC., Edmond, OK, USA.
⁴ Argires Marotti Neurosurgical Associates of Lancaster, Lancaster, PA, USA.
⁵ Anesis Spine & Pain Care, Renton, WA, USA.
⁶ Source Healthcare, Santa Monica, CA, USA.
⁷ Ascentist Healthcare, Leawood, KS, USA.
⁸ St Louis Pain Consultants, Chesterfield, MO, USA.
⁹ Crimson Pain Management Specialists, Overland Park, KS, USA.
¹⁰ Advanced Pain Institute, Lewisville, TX, USA.
¹¹ Northwest Pain Care, Spokane, WA, USA.
¹² Comprehensive Pain and Spine Specialists, Shelbyville, IN, USA.
¹³ Clearway Pain Solutions, Annapolis, MD, USA.
¹⁴ Pro Spine and Pain, Milwaukee, WI, USA.
¹⁵ University of Kentucky, Lexington, KY, USA.

PMID: 40574607
DOI: 10.1093/pm/pnaf082

Abstract

Purpose: Sacroiliac joint (SIJ) pain, a frequent contributor to low back pain, is commonly treated with minimally invasive SIJ fusion. A large body of evidence supports the safety and effectiveness of lateral transiliac SIJ fusion. Traditionally performed by surgeons, this procedure is increasing in utilization by non-surgeon interventionalists. Herein, we present early safety results from a single-arm clinical trial of participants who underwent lateral SIJ fusion using threaded titanium implants placed by interventional pain management physicians.

Methods: STACI (NCT05870488) is a two-year prospective study conducted at 15 US interventional pain management sites. The primary endpoint is change in SIJ pain from baseline to 6-months. Secondary endpoints include changes in function (Oswestry Disability Index), quality of life (PROMIS-29), device or procedure-related adverse events, and evidence of fusion on CT scan at 2 years.

Results: 110 patients were enrolled. Mean (SD) participant age is 64 (14) years and 68% are female. Mean (SD) operative time was 44 minutes (16) and estimated blood loss was 14 cc (15). No serious or device-related adverse events have occurred. Reported perioperative adverse events include one surgical site infection and one hematoma. At 1-month follow-up, ODI improved by 18 points (p < 0.0001) and SIJ pain (NRS) decreased by 4 pts (p < 0.0001) from baseline.

Conclusion: Early results from this prospective multicenter study support the relative safety and early effectiveness of LTI SIJ fusion using a threaded implant when performed by interventional pain management physicians. The data are consistent with published literature with a low adverse event rate and early improvements in pain and function.

Keywords: 3D printed transfixing titanium implants; chronic low back pain; sacroiliac joint pain; transverse sacroiliac joint implants.

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