General Session: MIS - Hall F
Presented by: B. Sturesson
J. Dengler(1), D. Kools(2), R. Pflugmacher(3), A. Gasbarrini(4), D. Prestamburgo(5), P. Gaetani(6), D. Cher(7), B. Sturesson(8), P. Whang(9)
(1) Charité - Universitaetsmedizin Berlin, Neurosurgery, Berlin, Germany
(2) Onze-Lieve-Vrouw Hospital, Neurosurgery, Aalst, Belgium
(3) University Hospital Bonn, Department of Orthopedics and Traumatology, Bonn, Germany
(4) Instituto Ortopedico Rizzoli di Bologna, Department of Orthopedics, Bologna, Italy
(5) ASST Ovest Milanese - Ospedale di Legnano, Department of Orthopedics and Traumatology, Legnano, Italy
(6) Policlinico San Matteo, Department of Neurosurgery, Pavia, Italy
(7) SI-BONE, Inc., Clinical Affairs, San Jose, CA, United States
(8) Aleris, Ängelholm Hospital, Department of Orthopedics, Angelholm, Sweden
(9) Yale School of Medicine, Yale Orthopaedics/Spine Service, Orthopaedics, Milford, CT, United States
Purpose: To compare the 2-year safety and effectiveness of conservative management (CM) vs. SIJF with triangular titanium implants (TTI) in patients with chronic SIJ pain.
Study Design: Prospective, multicenter randomized controlled trial.
Methods: 103 adults in 9 European spine surgery clinics with chronic SIJ pain unresponsive to conservative treatment were assigned at random to either CM or SIJF with TTI. CM consisted of optimization of medical therapy, individualized physiotherapy and adequate information and reassurance as part of a multifactorial treatment. Endpoints include self-rated LBP on a 0-100 visual analog scale (VAS), leg pain, back dysfunction with Oswestry Disability Index (ODI), quality of life with EuroQOL-5D and Zung Depression Score, and SIJ function with active straight leg raise test (ASLR).
Results: At 24 months after SIJF, mean LBP improved by 45 points compared to baseline (p< .0001) and mean ODI improved by 26 points (p< .0001). Parallel improvements were seen in leg pain, quality of life measures and pelvic muscular function. In contrast, improvements in the CM group were minor (5.7 points for LBP and 5.8 points for ODI). All improvements after SIJF were statistically superior vs. CM. Subjects in the CM group who crossed over to SIJF showed improvements in all measures similar to those originally assigned to SIJF. One case of postoperative nerve impingement occurred in the surgical group. Two SIJF subjects had recurrent pain attributed to possible device loosening and 1 had postoperative hematoma. In the CM group, 1 crossover surgery subject had recurrent pain requiring a revision surgery.
Conclusions: For patients with chronic SIJ pain, minimally invasive SIJF with TTI was safe and effective at 2 years in improving pain, disability, quality of life and leg function. ClinicalTrials.gov number: NCT01741025