The 3-year LOIS study results include 103 subjects at 12 medical centers with SI joint dysfunction due to degenerative sacroiliitis or SI joint disruption who were evaluated in study clinics at study start and at 3, 4 and 5 years follow-up. 3-year follow-up was 93 percent. Mean preoperative SI joint pain was 81.5 (0 to 100 VAS) and decreased to 26.2 at 3-years, a 55-point improvement (Figure 1). Mean preoperative Oswestry Disability Index (ODI) was 56.3 and decreased to 28.2 at 3-years, a 28.1-point improvement (Figure 2).
"The 3-year LOIS results show that clinically significant improvements from both INSITE and SIFI patients were sustained at 3-years demonstrating that the benefits of SI joint fusion with iFuse are durable," said Emily Darr, M.D., Assistant Professor, Orthopaedic Surgery, Medical University of South Carolina College of Medicine and lead author on the publication. "Furthermore, the diagnosis of SI joint mediated pain has been described as challenging, but our results suggest that SI joint dysfunction can be reliably diagnosed through appropriate history, physical exam and response to diagnostic block and can be effectively treated."
"Based on the 56 peer-reviewed publications on iFuse, fourteen (14) commercial payers have established positive coverage policies for MIS SI joint fusion exclusively for the triangular iFuse Implant System from SI-BONE and no other SI joint fusion implants are covered by those payers," stated Daniel Cher, M.D., vice president of clinical affairs at SI-BONE.
1Darr E, Meyer SC, Whang PG, Kovalsky D, Frank C, Lockstadt H, Limoni R, Redmond A, Ploska P, Oh MY, Cher D, Chowdhary A. Long-term Prospective Outcomes After Minimally Invasive Trans-Iliac Sacroiliac Joint Fusion Using Triangular Titanium Implants. Medical Devices: Evidence and Research. 2018:11;113-121. doi: 10.2147/MDER.S160989.
2Polly DW, Swofford J, Whang PG, Frank CJ, Glaser JA, Limoni RP, Cher DJ, Wine KD, Sembrano JN, and the INSITE Study Group. Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction. Int J Spine Surg. 2016;10:Article 28. doi: 10.14444/3028.
3Duhon BS, Bitan F, Lockstadt H, Kovalsky DA, Cher DJ, Hillen T, on behalf of the SIFI Study Group. Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: 2-year Follow-up from a Prospective Multicenter Trial. Int J Spine Surg. 2016;10:Article 13. doi: 10.14444/3013.