Sacroiliac Joint Fusion Using Triangular Titanium Implants vs. Non-Surgical Management: Six-Month Outcomes from a Prospective Randomized Controlled Trial

148 patients with symptomatic sacroiliac joint dysfunction due to degenerative sacroiliitis and/or sacroiliac (SI) joint disruption were randomized to either nonsurgical management or minimally invasive joint fusion surgery. The purpose of this study was to compare the impact of both treatments on pain, disability, and function over a 6 month period. The primary study outcome was a success/failure composite endpoint (success was defined as a reduction from baseline VAS SI joint pain of 20mm, an absence of a device-related serious adverse event, an absence of neurological worsening related to the sacral spine and an absence of surgical re-intervention). The results of this trial indicated that significantly more patients who underwent the surgical procedure experienced success as defined by the composite endpoint (81.4% vs 23.9%) at 6 months. Patients in the surgical group also experienced significantly greater pain relief, improvement in quality of life and disability, and greater patient satisfaction compared to the nonsurgical management group, while experiencing a similar rate of adverse events per patient.