Prospective Trial of Sacroiliac Joint Fusion Using 3D-Printed Triangular Titanium Implants
Patel, V.; Kovalsky, D.; Meyer, S.C.; Chowdhary, A.; Lockstadt, H.; Techy, F.; Langel, C.; Limoni, R.; Yuan, P.S.; Kranenburg, A.; Cher, D.; Tender, G.; Hillen, T.J.
Medical Devices 13: 173-182
ISSN/ISBN: 1179-1470 PMID: 32607011 DOI: 10.2147/mder.s253741
Prior trials provide strong evidence supporting minimally invasive sacroiliac joint (SIJ) fusion using triangular titanium implants (TTI) for chronic SIJ dysfunction. To assess the safety and effectiveness of SIJF using a 3D-printed TTI. 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. 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. 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 II.