Clinical Data
SALLY 2-year Results (Patel - MDER 2021)
Prospective Trial of Sacroiliac Joint Fusion Using 3D-Printed Triangular Titanium Implants: 24-Month Follow-Up
Patel V, Kovalsky D, Meyer SC, Chowdhary A, LaCombe J, Lockstadt H, Techy F, Langel C, Limoni R, Yuan P, Kranenburg A, Cher D, Tender G.
Med Devices (Auckl). 2020;14:211-216. [ePub 29 June 2021].
DOI: 10.2147/MDER.S314828
ABSTRACT
Background: Strong evidence supports minimally invasive sacroiliac joint (SIJ) fusion using triangular titanium implants (TTI) for chronic SIJ dysfunction.
Objective: To report safety and effectiveness of SIJF using a 3D-printed TTI at 24 months.
Methods: 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.
Results: 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.
Conclusion: 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 of Evidence: Level II.
Keywords: sacroiliac joint pain, sacroiliac joint arthrodesis, chronic low back pain, triangular titanium implants
Author Information
Patel V - Department of Orthopedics, University of Colorado, Aurora, CO, USA
Kovalsky D - Orthopaedic Center of Southern Illinois, Mt. Vernon, IL, USA
Meyer SC - Columbia Orthopaedic Medical Group, Columbia, MO, USA
Chowdhary A & LaCombe J - Overlake Medical Center, Bellevue, WA, USA
Lockstadt H - Bluegrass Orthopaedics, Lexington, KY, USA
Techy F - ClinTech Center for Spine Health, Johnstown, CO, USA
Langel C - The B.A.C.K. Center, Melbourne, FL, USA
Limoni R - BayCare Clinic Orthopedics & Sports Medicine, Green Bay, WI, USA
Yuan PS - Memorial Orthopaedic Surgical Group, Long Beach, CA, USA
Kranenburg A - South Oregon Orthopedics, Medford, OR, USA
Cher D - SI-BONE, Inc., Santa Clara, CA, USA
Tender G - Department of Neurosurgery, Louisiana State University, New Orleans, LA, USA