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

Abstract

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.

Keywords:

• sacroiliac joint pain
• sacroiliac joint arthrodesis
• chronic low back pain
• triangular titanium implants

Disclosure

All authors conduct clinical research as part of prospective trials sponsored by SI-BONE. Abhineet Chowdhary, Travis J Hillen, Don Kovalsky, Andy Kranenburg, Harry Lockstadt, S. Craig Meyer, Vikas Patel and Gabriel Tender are paid consultants to SI-BONE.  Daniel Cher is an employee of SI-BONE. Dr Vikas Patel reports grants from Pfizer, Orthofix, Globus, Medicrea, Mainstay and personal fees from DePuy-Synthes, SLACK Inc, Zimmer-Biomet, Aesculap, outside the submitted work. Dr S. Craig Meyer reports personal fees from Columbia Orthopaedic Group Clinical Research Foundation, during the conduct of the study. Dr Philip S Yuan reports personal fees from Choice Spine, outside the submitted work. Dr Travis J Hillen reports personal fees from Medtronic and Unltragenyx and is consultant for ERT, outside the submitted work. The authors report no other conflicts of interest in this work.