Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: A Prospective Study
Duhon BS, et al. Global Spine J. 2015. Epub 2015 Aug 11. doi: 10.1055/s-0035-1562912
Study Design - Prospective multicenter single-arm interventional clinical trial.
Objective - To determine the degree of improvement in sacroiliac (SI) joint pain, disability related to SI joint pain, and quality of life in patients with SI joint dysfunction who undergo minimally invasive SI joint fusion using triangular-shaped titanium implants.
Methods - Subjects (n ¼ 172) underwent minimally invasive SI joint fusion between August 2012 and January 2014 and completed structured assessments preoperatively and at 1, 3, 6, and 12 months postoperatively, including a 100-mmSI joint and back pain visual analog scale (VAS), Oswestry Disability Index (ODI), Short Form-36 (SF-36), and EuroQOL-5D. Patient satisfaction with surgery was assessed at 6 and 12 months.
Results - Mean SI joint pain improved from 79.8 at baseline to 30.0 and 30.4 at 6 and 12 months, respectively (mean improvements of 49.9 and 49.1 points, p < 0.0001 each). Mean ODI improved from 55.2 at baseline to 32.5 and 31.4 at 6 and 12 months (improvements of 22.7 and 23.9 points, p < 0.0001 each). SF-36 physical component summary improved from 31.7 at baseline to 40.2 and 40.3 at 6 and 12 months (p < 0.0001). At 6 and 12months, 93 and 87% of subjects, respectively, were somewhat or very satisfied and 92 and 91%, respectively, would have the procedure again.
Conclusions - Minimally invasive SI joint fusion resulted in improvement of pain, disability, and quality of life in patients with SI joint dysfunction due to degenerative sacroiliitis and SI joint disruption.
Bradley S. Duhon1†* Daniel J. Cher2‡ Kathryn D. Wine2‡ Don A. Kovalsky3† Harry Lockstadt4†* on behalf of the SIFI Study Group
1 Neurosurgical and Spine Specialists, Parker, Colorado, United States
2 Clinical Affairs, SI-BONE, San Jose, California, United States
3 Orthopaedic Center of Southern Illinois, Mt Vernon, Illinois, United States
4 Bluegrass Orthopaedics and Hand Care, Lexington, Kentucky, United States
‡ Employee of SI-BONE, Inc.
* Paid consultant of SI-BONE, Inc.
† Conducts clinical research for SI-BONE, Inc.