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

Vikas Patel1, Don Kovalsky2, S Craig Meyer3

  • 1Department of Orthopedics, University of Colorado, Aurora, CO, USA.

Medical Devices (Auckland, N.Z.)
|July 8, 2021
PubMed
Summary

Minimally invasive sacroiliac joint (SIJ) fusion using 3D-printed triangular titanium implants (TTI) offers significant, lasting relief from chronic SIJ dysfunction. This procedure improves pain, quality of life, and physical function with minimal adverse events.

Keywords:
chronic low back painsacroiliac joint arthrodesissacroiliac joint paintriangular titanium implants

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Area of Science:

  • Orthopedic surgery
  • Spinal fusion techniques
  • Biomaterials in medicine

Background:

  • Chronic sacroiliac joint (SIJ) dysfunction significantly impacts patient quality of life.
  • Minimally invasive SIJ fusion using triangular titanium implants (TTI) is a recognized treatment.
  • Evaluating novel 3D-printed TTI designs is crucial for advancing SIJ fusion.

Purpose of the Study:

  • To assess the safety and effectiveness of sacroiliac joint fusion (SIJF) utilizing a 3D-printed TTI.
  • To evaluate outcomes at a 24-month follow-up period.
  • To analyze improvements in pain, quality of life, and physical function.

Main Methods:

  • Prospective study involving 51 subjects undergoing SIJF with a 3D-printed TTI.
  • Structured follow-up assessments at 3, 6, 12, and 24 months.
  • Utilized quality of life questionnaires (e.g., Oswestry Disability Index) and functional tests.

Main Results:

  • 84% of subjects completed the 24-month follow-up.
  • Significant and persistent reductions in Oswestry Disability Index scores (mean 52.8 to 28.3) and SIJ pain ratings (mean 78.5 to 21.5) were observed (p<0.0001).
  • Marked decrease in opioid use, improved physical function, and no device-related adverse events like breakage or migration were reported.

Conclusions:

  • SIJF with 3D-printed TTI provides immediate, substantial, and sustained improvements in pain and quality of life.
  • The procedure enhances physical function and reduces reliance on opioid medication.
  • A low incidence of late, device-related adverse events supports the safety profile of this innovative implant.