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

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.