General Session: MIS - Hall F
Presented by: P. Whang
P. Whang(1), C. Frank(2), H. Lockstadt(3), S.C. Meyer(4), D. Kovalsky(5), A. Redmond(6), E. Darr(7), D. Cher(8), M. Oh(9)
(1) Yale University, Department of Orthopedics, New Haven, CT, United States
(2) Integrated Spine Care, Wauwatosa, WI, United States
(3) Bluegrass Orthopedics, Lexington, KY, United States
(4) Columbia Orthopedics, Columbia, MO, United States
(5) Orthopedic Center of Southern Illinois, Mt. Vernon, IL, United States
(6) Precision SPine Care, Tyler, TX, United States
(7) Medical University of South Carolina, Physical Medicine & Rehabilitation, Charleston, SC, United States
(8) SI-BONE, Inc., Clinical Affairs, San Jose, CA, United States
(9) Allegheny Medical Center, Neurosurgery, Pittsburgh, PA, United States
Purpose: To report 3-year clinical and functional outcomes of minimally invasive SIJF using triangular titanium implants (TTI) for the treatment of chronic SI joint dysfunction due to degenerative sacroiliitis or sacroiliac joint disruption.
Methods: 103 subjects with SIJ dysfunction at 12 centers were treated with TTI in two prospective clinical trials (NCT01640353 and NCT01681004) and enrolled in this long-term follow-up study (NCT02270203).
Results: Mean (SD) preoperative SIJ pain score was 81.5 and mean preoperative Oswestry Disability Index (ODI) was 56.3. At 3 years, mean pain SIJ pain score decreased to 26.2 (a 56-point improvement from baseline, p< .0001). At 3 years, mean ODI was 28.2 (a 28-point improvement from baseline, p< .0001). 82% were very satisfied with the procedure at 3 years. EQ-5D time trade-off index improved by 0.30 points (p< .0001). No adverse events definitely related to the study device or procedure were reported; one subject underwent revision surgery at year 3.7. SIJ pain contralateral to the originally treated side occurred in 15 subjects of whom 4 underwent contralateral SIJF.
Conclusions: 3-year prospective follow-up showed that minimally invasive trans-iliac SIJF with TTI was associated with improved pain, disability and quality of life as well as high satisfaction rates.