General Session: MIS-2
Presented by: D. Cher - View Audio/Video Presentation (Members Only)
J. Dengler(1), D. Cher(2), D. Polly(3), B. Duhon(4), C. Frank(5), J. Glaser(6), B. Sturesson(7), S. Garfin(8), A. Rendahl(9)
(1) Charité - Universitaetsmedizin Berlin, Neurosurgery, Berlin, Germany
(2) SI-BONE, Inc., Clinical Affairs, San Jose, CA, United States
(3) University of Minnesota, Orthopedics and Neurosurgery, Minneapolis, MN, United States
(4) University of Colorado Anschutz Medical Campus, Neurosurgery, Aurora, CO, United States
(5) Integrated Spine Care, Orthopedics, Wawautosa, WI, United States
(6) Medical University of South Carolina, Orthopedics, Charleston, SC, United States
(7) Aleris Angelholm Hospital, Orthopedics, Angelholm, Sweden
(8) University of California at San Diego, Orthopedics, San Diego, CA, United States
(9) University of Minnesota, Statistics, Minneapolis, MA, United States
Background: Increasing evidence supports the safety and effectiveness of minimally invasive sacroiliac joint fusion (SIJF) for SIJ dysfunction, including prospective multicenter clinical trials.
Methods: 3 multicenter prospective clinical trials of minimally invasive SIJF using triangular titanium implants were combined on an individual patient basis and analyzed statistically using mixed modeling.
Results: The three trials included 423 subjects and two geographies (US and Europe). Mean age was 50 years and 70.4% of subjects were women. Mean duration of pain prior to enrollment was >5 years. SIJ pain ratings (0-100 scale) averaged 80 points at baseline. In the SIJF group, pain levels dropped by 48 (44-52) points at 12 months and 52 (47-56) points at 24 months. Mean reductions in ODI in the SIJF group were 26 (22-29) and 26 (22-30) points at 12 and 24 months, respectively. In the NSM groups, changes in pain and ODI scores were minimal. Effect sizes (i.e., the differential in improvement in scores observed with surgery as opposed to non-surgical treatment) were 37.8 points (95% CI 32.4-43.2) for VAS SIJ pain, 18.4 points (95% CI 14.3-22.4) for ODI, and 0.24 points (95% CI 0.17-0.30) for EQ-5D. Wound-related complications (e.g., infection) occurred in 2.1% (95% CI 0.3-4.4%). The early surgical revision rate was 1.2% (0.4-2.5%) and the late revision rate was 1.6% (0.1-5.1%).
Conclusions: Level 1a evidence from 3 prospective clinical trials, including 2 surgery vs. non-surgery trials, provides strong evidence to support the safety and effectiveness of minimally invasive SIJF using triangular titanium implants.