Medical Devices: Evidence and Research (May 2019)

Minimally invasive lateral transiliac sacroiliac joint fusion using 3D-printed triangular titanium implants

  • Patel V,
  • Kovalsky D,
  • Meyer SC,
  • Chowdhary A,
  • Lockstadt H,
  • Techy F,
  • Billys J,
  • Limoni R,
  • Yuan PS,
  • Kranenburg A,
  • Cher D,
  • Tender G

Journal volume & issue
Vol. Volume 12
pp. 203 – 214

Abstract

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Vikas Patel,1 Don Kovalsky,2 S Craig Meyer,3 Abhineet Chowdhary,4 Harry Lockstadt,5 Fernando Techy,6 James Billys,7 Robert Limoni,8 Philip S Yuan,9 Andy Kranenburg,10 Daniel Cher,11 Gabriel Tender121Department 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, USABackground: Minimally invasive sacroiliac joint (SIJ) fusion (SIJF) has become an increasingly accepted surgical option for chronic SI joint dysfunction, a prevalent cause of chronic low back/buttock pain.Objective: To report clinical and functional outcomes of SIJF using 3D-printed triangular titanium implants (TTI) for patients with chronic SI joint dysfunction.Methods: A total of 28 subjects with SIJ dysfunction at 8 centers underwent SIJF with 3D TTI and had scheduled follow-up to 6 months (NCT03122899).Results: Mean preoperative SIJ pain score was 79.1 and mean preoperative Oswestry Disability Index (ODI) was 49.9. At 6 months, pain scores decreased by 51 points and ODI decreased by 23.6 points (both p<0.0001). The proportion of subjects able to perform various back/pelvis-related physical functions with minimal difficulty improved significantly for nearly all activities. Opioid use decreased and physical function, as assessed with three objective tests, improved.Conclusion: Early results from this prospective multicenter trial confirm that clinical responses to a 3D triangular titanium implant for SIJF are similar to those from prior trials, with improved physical function and decreased opioid use.Level of evidence: Level II.Keywords: spine surgery, pelvic pain, osteoarthritis, arthrodesis

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