Clinical Data
STACI 2-year Results (Weisbein - Pain Med 2025)
Safety and Initial Effectiveness of Minimally Invasive Sacroiliac Joint Fusion with Metal Implants using a Lateral Transiliac Approach: A Prospective Trial
Weisbein J, Patterson D, Beall D, Nguyen D, Smith J, Harstroem C, Davis T, Foster J, Christopher A, Kloster D, Broadnax J, Anderson E, Hatheway J, Trobridge A, Simmons C, Stauss T, Harned M, Mallard C.
Pain Med. 2025 Jun 26:pnaf082.
doi: 10.1093/pm/pnaf082. PMID: 40574607. [Epub Ahead of Print]
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.
Author Information
Weisbien J - Napa Valley Orthopaedics, Napa, CA, USA.
Patterson D - Nevada Advanced Pain Specialists, Reno, NV, USA.
Beall D, Nguyen D - Clinical Investigations, LLC., Edmond, OK, USA.
Smith J - Argires Marotti Neurosurgical Associates of Lancaster, Lancaster, PA, USA.
Harstroem C - Anesis Spine & Pain Care, Renton, WA, USA.
Davis T - Source Healthcare, Santa Monica, CA, USA.
Foster J - Ascentist Healthcare, Leawood, KS, USA.
Christopher A - St Louis Pain Consultants, Chesterfield, MO, USA.
Kloster D - Crimson Pain Management Specialists, Overland Park, KS, USA.
Broadnax J, Anderson E - Advanced Pain Institute, Lewisville, TX, USA.
Hatheway J - Northwest Pain Care, Spokane, WA, USA.
Trobridge A - Comprehensive Pain and Spine Specialists, Shelbyville, IN, USA.
Simmons C - Clearway Pain Solutions, Annapolis, MD, USA.
Stauss T - Pro Spine and Pain, Milwaukee, WI, USA.
Harned N, Mallard C - University of Kentucky, Lexington, KY, USA.