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

Abstract

Background: 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

Data sharing statement

Study data are available to qualified requestors through Yale University’s Yale Open Data Access (YODA) platform; provided data include de-identified study data, study protocol, and case report forms.

Disclosure

All authors conduct clinical research as part of prospective trials sponsored by SI-BONE. S Craig Meyer, Harry Lockstadt, Andy Kranenburg, Abhineet Chowdhary and James Billys are consultants to SI-BONE and are involved in teaching about SIJ pain/surgery and/or product development. Dr Vikas Patel reports grants from SI-BONE, during the conduct of the study as well as grants from Medicrea, Globus, Mainstay, Premia, Orthofix, Aesculap, Springer, and ZimmerBiomet, outside the submitted work. Dr Fernando Techy reports personal fees from Spine Way, Grafton Medical, and Spine Frontier. He also received grants from Orthofix, M6, and personal fees from Spine Wave, outside the submitted work. Dr Daniel Cher is employed by SI-BONE. The authors report no other conflicts of interest in this work.