Prospective Trial of Sacroiliac Joint Fusion Using 3D-Printed Triangular Titanium Implants

Vikas Patel, University of Colorado
Don Kovalsky, Orthopaedic Center of Southern Illinois
S Craig Meyer, Columbia Orthopaedic Medical Group
Abhineet Chowdhary, Overlake Medical Center
Harry Lockstadt, Bluegrass Orthopaedics
Fernando Techy, ClinTech Center for Spine Health
Casey Langel, The B.A.C.K. Center
Robert Limoni, BayCare Clinic Orthopedics & Sports Medicine
Philip S. Yuan, Memorial Orthopaedic Surgical Group
Andy Kranenburg, South Oregon Orthopedics
Daniel Cher, SI-BONE, Inc.
Gabriel Tender, LSU Health Sciences Center - New Orleans
Travis J. Hillen, Washington University


Background: 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.