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Clinical Data

SALLY 1-year Results (Patel - MDER 2020)

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

Patel V, Kovalsky D, Meyer SC, Chowdhary A, Lockstadt H, Techy F, Langel C, Limoni R, Yuan PS, Kranenburg A, Cher D, Tender G, Hillen TJ
Med Devices (Auckl). 2020;13:173-182. eCollection 2020.
DOI: 10.2147/MDER.S253741

ABSTRACT

Background: Prior trials provide strong evidence supporting minimally invasive sacroiliac joint 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

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 - 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
Hillen TJ - Department of Musculoskeletal Radiology, Washington University St. Louis, St. Louis, MO

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