SALLY 6-month Interim Results (Patel - MDER 2019) | SI-BONE

Clinical Data

SALLY 6-month Interim Results (Patel - MDER 2019)

Minimally Invasive Lateral Transiliac Sacroiliac Joint Fusion Using 3D-Printed Triangular Titanium Implants

Patel V, Kovalsky D, Meyer SC, Chowdhary A, Lockstadt H, Techy F, Billys J, Limoni R, Yuan P, Kranenburg A, Cher D, Tender G.
Med Devices (Auckl). 2019;12:203-214. [Epub 2019 May 27].
PMID: xxxxxxxxx. DOI: 10.2147/MDER.S205812


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 all activities. Opioid use decreased and physical function, as assessed with three objective tests, improved.

Conclusions: 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: II

Author Information

  • Patel V -
  • Kovalsky D -
  • Meyer SC -
  • Chowdhary A -
  • Lokcstadt H - h
  • Techy F -
  • Billys J -
  • Limoni R -
  • Yuan P -
  • Kranenburg A -
  • Cher D -
  • Tender G -

Disclosure: The study was funded by SI-BONE (Santa Clara, California), the manufacturer of the iFuse Implant System used in the study. One author of this study (D.C.) is an employee at SI-BONE.

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