TY - JOUR
T1 - Randomized Trial of Augmented Pelvic Fixation in Patients Undergoing Thoracolumbar Fusion for Adult Spine Deformity
T2 - Initial Results from a Multicenter Randomized Trial
AU - SILVIA Investigator Group
AU - Polly, David
AU - Mundis, Greg
AU - Eastlack, Robert
AU - Leveque, Jean Christopher
AU - Elder, Benjamin D.
AU - Martin, Christopher
AU - Kent, Roland
AU - Snowden, Ryan
AU - Kim, Han Jo
AU - Sembrano, Jonathan
AU - Herzog, Joshua
AU - Lieberman, Isador
AU - Matheus, Virgilio
AU - Buchholz, Avery
AU - Franke, Jorg
AU - Lee, Robert
AU - Shaffrey, Christopher
AU - Mundis, Gregory
AU - Klapproth, Lars
AU - Leveque, Jean Christophe
AU - Arakal, Raj
AU - Chapman, Matt
AU - Khan, Safdar
AU - Belanger, Theodore
AU - Wong, Cyrus
AU - Ajayi, Olaide
AU - Kazemi, Noojan
AU - Park, Paul
AU - Singla, Anuj
AU - Buckland, Aaron
AU - Hah, Raymond
AU - Khalil, Jad
AU - Kleck, Christopher
AU - Mokawem, Michael
AU - Nemani, Venu
AU - Turner, Jay
AU - Colman, Matt
AU - Hirschl, Robert
AU - Kuhns, Craig
AU - Prestamburgo, Domenico
AU - Sethi, Rajiv
AU - Smith, Gregory
AU - Uribe, Juan
AU - Cress, Marshall C.
AU - Dewald, Christopher
AU - Fogelson, Jeremy
AU - Martin, Chris
AU - Meiler, Katherine
AU - Mullin, Jeffrey
AU - Oppenlander, Mark
N1 - Publisher Copyright: © 2024
PY - 2024/7
Y1 - 2024/7
N2 - Background: The optimal configuration for spinopelvic fixation during multilevel spine fusion surgery for adult spine deformity remains unclear. Postoperative sacroiliac (SI) joint pain, S2AI screw loosening and implant breakage could be related to continued motion of the SI joint with use of only a single point of fixation across the SI joint. Methods: Prospective, international, multicenter randomized controlled trial of 222 patients with adult spine deformity scheduled for multilevel (4 or more levels) spine fusion surgery with pelvic fixation. Subjects were randomized to sacroalar (S2) iliac (S2AI) screws alone for pelvic fixation or S2AI + triangular titanium implants placed cephalad to S2AI screws. Quad rod techniques were not allowed or used. Baseline spinal deformity measures were read by an independent radiologist. Site-reported perioperative adverse events were reviewed by a clinical events committee. Quality of life questionnaires and other clinical outcomes are in process with planned 2-year follow-up. Results: One hundred thirteen participants were assigned to S2AI and 109 to S2AI + titanium triangular implants (TTI). 35/222 (16%) of all subjects had a history of SI joint pain or were diagnosed with SI joint pain during preoperative workup. Three-month follow-up was available in all but 4 subjects. TTI placement was successful in 106 of 109 (98%) subjects assigned to TTI. In 2 cases, TTI could not be placed due to anatomical considerations. Three TTI ventral iliac breaches were observed, all of which were managed non-surgically. One TTI subject had a transverse sacral fracture and 1 TTI subject had malposition of the implant requiring removal. Conclusions: SI joint pain is common in patients with adult spinal deformity who are candidates for multilevel spine fusion surgery. Concurrent placement of TTI parallel to S2AI screws during multilevel spine fusion surgery is feasible and safe. Further follow-up will help to determine the clinical value of this approach to augment pelvic fixation.
AB - Background: The optimal configuration for spinopelvic fixation during multilevel spine fusion surgery for adult spine deformity remains unclear. Postoperative sacroiliac (SI) joint pain, S2AI screw loosening and implant breakage could be related to continued motion of the SI joint with use of only a single point of fixation across the SI joint. Methods: Prospective, international, multicenter randomized controlled trial of 222 patients with adult spine deformity scheduled for multilevel (4 or more levels) spine fusion surgery with pelvic fixation. Subjects were randomized to sacroalar (S2) iliac (S2AI) screws alone for pelvic fixation or S2AI + triangular titanium implants placed cephalad to S2AI screws. Quad rod techniques were not allowed or used. Baseline spinal deformity measures were read by an independent radiologist. Site-reported perioperative adverse events were reviewed by a clinical events committee. Quality of life questionnaires and other clinical outcomes are in process with planned 2-year follow-up. Results: One hundred thirteen participants were assigned to S2AI and 109 to S2AI + titanium triangular implants (TTI). 35/222 (16%) of all subjects had a history of SI joint pain or were diagnosed with SI joint pain during preoperative workup. Three-month follow-up was available in all but 4 subjects. TTI placement was successful in 106 of 109 (98%) subjects assigned to TTI. In 2 cases, TTI could not be placed due to anatomical considerations. Three TTI ventral iliac breaches were observed, all of which were managed non-surgically. One TTI subject had a transverse sacral fracture and 1 TTI subject had malposition of the implant requiring removal. Conclusions: SI joint pain is common in patients with adult spinal deformity who are candidates for multilevel spine fusion surgery. Concurrent placement of TTI parallel to S2AI screws during multilevel spine fusion surgery is feasible and safe. Further follow-up will help to determine the clinical value of this approach to augment pelvic fixation.
KW - Pelvic fixation
KW - Randomized trial
KW - Sacroiliac joint pain
KW - Spine fusion
KW - Spinopelvic construct failures
UR - https://www.scopus.com/pages/publications/85192942430
U2 - 10.1016/j.wneu.2024.01.156
DO - 10.1016/j.wneu.2024.01.156
M3 - Article
C2 - 38310950
SN - 1878-8750
VL - 187
SP - e15-e27
JO - World Neurosurgery
JF - World Neurosurgery
ER -