Medical Devices: Evidence and Research (Aug 2018)
Four-year outcomes after minimally invasive transiliac sacroiliac joint fusion with triangular titanium implants
Abstract
Emily Darr,1 Daniel Cher2 1Physical Medicine & Rehabilitation, Medical University of South Carolina, Charleston, SC, USA; 2Clinical Affairs, SI-BONE, Inc., Santa Clara, CA, USA Background: Increasing long-term evidence supports the safety and effectiveness of minimally invasive sacroiliac joint fusion (SIJF) for sacroiliac joint (SIJ) dysfunction, an important cause of chronic low-back/buttock pain. Objective: To report 4-year follow-up in patients undergoing SIJF using triangular titanium implants (TTI) as part of two prospective trials. Methods: We enrolled 103 subjects at 12 centers treated with TTI in two prospective clinical trials (NCT01640353 and NCT01681004) and followed them in the current study (NCT02270203), with clinic visits at 3, 4, and 5 years. Results: At 4 years, mean SIJ pain scores (available in 91 subjects [88.3%]) had decreased by 54 points from baseline; disability (Oswestry Disability Index) scores decreased by 26 points; and quality of life (EuroQOL-5D) improved by 0.3 points (0–1 scale). Satisfaction rates were high and the proportion of subjects taking opioids decreased from 77% at baseline to 43% at 4-year follow-up. Conclusion: Four-year follow-up showed continued excellent responses in patients with SIJ pain treated with SIJF using triangular titanium implants. Keywords: sacroiliac joint fusion, chronic low back pain, multicenter prospective trial
