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Vikas Patel,1 Don Kovalsky,2 S Craig Meyer,3 Abhineet Chowdhary,4 Harry Lockstadt,5 Fernando Techy,6 Casey Langel,7 Robert Limoni,8 Philip S Yuan,9 Andy Kranenburg,10 Daniel Cher,11 Gabriel Tender,12 Travis J Hillen13 1Department of Orthopedics, University of Colorado, Aurora, CO, USA; 2Orthopaedic Center of Southern Illinois, Mt. Vernon, IL, USA; 3Columbia Orthopaedic Medical Group, Columbia, MO, USA; 4Overlake Medical Center, Bellevue, WA, USA; 5Bluegrass Orthopaedics, Lexington, KY, USA; 6ClinTech Center for Spine Health, Johnstown, CO, USA; 7The B.A.C.K. Center, Melbourne, FL, USA; 8BayCare Clinic Orthopedics & Sports Medicine, Green Bay, WI, USA; 9Memorial Orthopaedic Surgical Group, Long Beach, CA, USA; 10South Oregon Orthopedics, Medford, OR, USA; 11SI-BONE, Inc., Santa Clara, CA, USA; 12Department of Neurosurgery, Louisiana State University, New Orleans, LA, USA; 13Department of Musculoskeletal Radiology, Washington University St. Louis, St. Louis, MOCorrespondence: Vikas Patel Tel +1 303 724-8936Email Vikas.Patel@CUAnschutz.eduBackground: Prior trials provide strong evidence supporting minimally invasive sacroiliac joint (SIJ) fusion using triangular titanium implants (TTI) for chronic SIJ dysfunction.Objective: To assess the safety and effectiveness of SIJF using a 3D-printed TTI.Methods: Fifty-one subjects with carefully diagnosed SIJ dysfunction underwent SIJF with 3D TTI. Subjects completed pain, disability and quality of life questionnaires at baseline and 3, 6 and 12 months postoperatively. Functional tests were performed in the clinic at each visit. Pelvic CT scans were independently evaluated for radiolucency, bridging bone and other endpoints.Results: Ninety percent had 12-month follow-up. Dysfunction due to pain (Oswestry Disability Index [ODI]) decreased from 52.8 at baseline to 27.9 at 12 months (p< .0001 for change, p=.004 for non-inferiority primary hypothesis). SIJ pain scores improved from 78 preoperatively to 21 at 12-month follow-up (P< .0001). Ninety-six percent experienced an improvement of 20 points or more in VAS SIJ pain by month 12. The percentage of subjects reporting minimal difficulty performing physical activities typically impaired by back/SIJ pain improved significantly for all activities. The proportion of subjects taking opioids for SIJ pain decreased from 57% to 22%. Three physical function tests improved markedly from baseline to 1 year. Positive radiographic findings were observed, including a 70% and 77% rate of bone bridging observed at 6 and 12 months, respectively. There was no evidence of device breakage, migration or subsidence.Conclusion: In this prospective multicenter trial, SIJF with 3D-printed TTI markedly improved pain, disability and quality of life. Results are consistent with 3 prior prospective multicenter trials of a milled implant but suggest accelerated bony fusion with the newer implant. Physical function improved, and high rates of opioid cessation were observed.Level of Evidence: Level II.Keywords: sacroiliac joint pain, sacroiliac joint arthrodesis, chronic low back pain, triangular titanium implants |
