Medical Devices: Evidence and Research (Sep 2019)

Long-Term Prospective Clinical And Radiographic Outcomes After Minimally Invasive Lateral Transiliac Sacroiliac Joint Fusion Using Triangular Titanium Implants

  • Whang PG,
  • Darr E,
  • Meyer SC,
  • Kovalsky D,
  • Frank C,
  • Lockstadt H,
  • Limoni R,
  • Redmond AJ,
  • Ploska P,
  • Oh M,
  • Chowdhary A,
  • Cher D,
  • Cher D,
  • Hillen T

Journal volume & issue
Vol. Volume 12
pp. 411 – 422

Abstract

Read online

Peter G Whang,1 Emily Darr,2 S Craig Meyer,3 Don Kovalsky,4 Clay Frank,5 Harry Lockstadt,6 Robert Limoni,7 Andy J Redmond,8 Philip Ploska,9 Michael Oh,10 Abhineet Chowdhary,11 Daniel Cher,12 Travis Hillen13 1Department of Orthopedics and Rehabilitation, Yale University School of Medicine, New Haven, CT, USA; 2Department of Orthopaedics, Medical University of South Carolina, Charleston, SC, USA; 3Columbia Orthopaedic Medical Group, Columbia, Mo, USA; 4Orthopaedic Center of Southern Illinois, Mt. Vernon, IL, USA; 5Integrated Spine Care, Wawautosa, WI, USA; 6Bluegrass Orthopedics, Lexington, KY, USA; 7BayCare Clinic Orthopedics and Sports Medicine, Green Bay, WI, USA; 8Precision Spine Care, Tyler, TX, USA; 9OrthoSpine Solutions, Stockbridge, GA, USA; 10Department of Neurosurgery, Allegheny General Hospital, Pittsburgh, PA, USA; 11Neuroscience Institute, Overlake Hospital, Bellevue, WA, USA; 12Clinical Affairs, SI-BONE, Inc, Santa Clara, CA, USA; 13Department of Radiology, Division of Diagnostic Radiology, Musculoskeletal Section, Washington University St. Louis, St. Louis, MO, USACorrespondence: Peter G WhangDepartment of Orthopaedics and Rehabilitation, Yale University School of Medicine, P.O. Box 208071, New Haven, CT 06520-8071, USAEmail [email protected]: Accumulating evidence supports the long-term safety and effectiveness of minimally invasive sacroiliac joint fusion (SIJF) for sacroiliac joint dysfunction.Objective: To report 5-year clinical and radiographic follow-up in patients undergoing SIJF using triangular titanium implants (TTI).Methods: One hundred and three subjects at 12 centers treated with SIJF using TTI in two prospective clinical trials (NCT01640353 and NCT01681004) were enrolled and followed in the current study (NCT02270203) with clinic visits at 3, 4 and 5 years. CT scans performed at 5 years were compared to prior CT scans (at 1 or 2 years) by an independent radiologist.Results: Compared to baseline scores, SIJ pain scores at 5 years decreased by a mean of 54 points, disability scores (Oswestry Disability Index) decreased by 26 points, and quality of life scores (EuroQOL-5D time trade-off index) increased by 0.29 points (0–1 scale) (all p<0.0001). Satisfaction rates were high and the proportion of subjects taking opioids decreased from 77% at baseline to 41% at 5-year follow-up. Independent radiographic analysis showed a high rate (98%) of bone apposition to implants on both the sacral and iliac sides of the SI joint, with a high rate of bony bridging (87%) and a low rate of radiolucencies suggestive of loosening (5%).Conclusion: A 5-year follow-up showed continued excellent clinical responses in patients with SIJ pain treated with SIJF using triangular titanium implants along with a high rate (88%) of joint fusion.Level of evidence: Level II.Keywords: sacroiliac joint pain, sacroiliac joint degeneration, arthrodesis, sacroiliac joint fusion

Keywords