Prospective Trial of Sacroiliac Joint Fusion Using 3D-Printed Triangular Titanium Implants: 24-Month Follow-Up

Patel, V.; Kovalsky, D.; Meyer, S.C.; Chowdhary, A.; LaCombe, J.; Lockstadt, H.; Techy, F.; Langel, C.; Limoni, R.; Yuan, P.; Kranenburg, A.; Cher, D.; Tender, G.

Medical Devices 14: 211-216

2021


ISSN/ISBN: 1179-1470
PMID: 34234582
Accession: 072384375

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Abstract
Strong evidence supports minimally invasive sacroiliac joint (SIJ) fusion using triangular titanium implants (TTI) for chronic SIJ dysfunction. To report safety and effectiveness of SIJF using a 3D-printed TTI at 24 months. SIJF with TTI was performed in 51 subjects. Structured follow-up occurred at 3, 6, 12 and 24 months. Both quality of life questionnaires and functional tests were performed at all study visits. 84% of subjects were available for 24-month follow-up. Observed were rapid and persistent improvements in dysfunction due to pain (Oswestry Disability Index [ODI], mean 52.8 at baseline and 28.3 at 24 months, p<0.0001) and SIJ pain ratings (mean 78.5 at baseline [0-100 scale] to 21.5 at 24 months). Opioid use for SIJ pain decreased markedly from baseline. Physical function tests impaired by SIJ pain showed persistent improvements compared to baseline. There was no evidence of device breakage, migration or subsidence and few late adverse events occurred attributable to the device. In this prospective study, SIJF using 3D-printed TTI resulted in immediate, marked and persistent improvements in pain and quality of life, with improved physical function, reduced opioid use and a low rate of late device-related adverse events. Level II.