1. Prospective Trial of Sacroiliac Joint Fusion Using 3D-Printed Triangular Titanium Implants: 24-Month Follow-Up
- Author
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Philip S Yuan, Harry Lockstadt, Abhineet Chowdhary, Don Kovalsky, Fernando Techy, Julie LaCombe, Vikas V. Patel, Gabriel C. Tender, Andy Kranenburg, Casey Langel, Robert Limoni, Daniel J. Cher, and S Craig Meyer
- Subjects
Sacroiliac joint ,3d printed ,business.industry ,Evidence and Research [Medical Devices] ,sacroiliac joint arthrodesis ,Biomedical Engineering ,Medicine (miscellaneous) ,Oswestry Disability Index ,sacroiliac joint pain ,medicine.anatomical_structure ,Quality of life ,Prospective trial ,Anesthesia ,medicine ,chronic low back pain ,Prospective cohort study ,business ,Adverse effect ,triangular titanium implants ,Month follow up ,Original Research - Abstract
Vikas Patel,1 Don Kovalsky,2 S Craig Meyer,3 Abhineet Chowdhary,4 Julie LaCombe,4 Harry Lockstadt,5 Fernando Techy,6 Casey Langel,7 Robert Limoni,8 Philip Yuan,9 Andy Kranenburg,10 Daniel Cher,11 Gabriel Tender12 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, USACorrespondence: Vikas Patel Tel +1 303 724-8936Email Vikas.Patel@CUAnschutz.eduBackground: Strong evidence supports minimally invasive sacroiliac joint (SIJ) fusion using triangular titanium implants (TTI) for chronic SIJ dysfunction.Objective: To report safety and effectiveness of SIJF using a 3D-printed TTI at 24 months.Methods: SIJF with TTI was performed in 51 subjects. Structured follow-up occurred at 3, 6, 12 and 24 months. Both quality of life questionnaires and functional tests were performed at all study visits.Results: 84% of subjects were available for 24-month follow-up. Observed were rapid and persistent improvements in dysfunction due to pain (Oswestry Disability Index [ODI], mean 52.8 at baseline and 28.3 at 24 months, p< 0.0001) and SIJ pain ratings (mean 78.5 at baseline [0â 100 scale] to 21.5 at 24 months). Opioid use for SIJ pain decreased markedly from baseline. Physical function tests impaired by SIJ pain showed persistent improvements compared to baseline. There was no evidence of device breakage, migration or subsidence and few late adverse events occurred attributable to the device.Conclusion: In this prospective study, SIJF using 3D-printed TTI resulted in immediate, marked and persistent improvements in pain and quality of life, with improved physical function, reduced opioid use and a low rate of late device-related adverse events.Level of Evidence: Level II.Keywords: sacroiliac joint pain, sacroiliac joint arthrodesis, chronic low back pain, triangular titanium implants
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- 2021