Display options
Share it on

Med Devices (Auckl). 2015 Nov 23;8:485-92. doi: 10.2147/MDER.S94885. eCollection 2015.

Implant survivorship analysis after minimally invasive sacroiliac joint fusion using the iFuse Implant System(®).

Medical devices (Auckland, N.Z.)

Daniel J Cher, W Carlton Reckling, Robyn A Capobianco

Affiliations

  1. Department of Clinical Affairs, SI-BONE, Inc. San Jose, CA, USA.
  2. Department of Medical Affairs, SI-BONE, Inc., San Jose, CA, USA.

PMID: 26648762 PMCID: PMC4664491 DOI: 10.2147/MDER.S94885

Abstract

INTRODUCTION: Surgical revision rate is a key outcome with all permanent implants. The iFuse Implant System(®) is a permanent implant used to perform minimally invasive sacroiliac joint fusion. The purpose of this study is to determine the surgical revision rate after sacroiliac joint fusion surgery with this system.

METHODS: Using two internal sources of information, revision surgeries were identified and linked to index surgeries. The likelihood of revision surgery was calculated using the Kaplan-Meier life table approach. Predictors of revision were explored.

RESULTS: Four-year survivorship free from implant revision was 96.46%. Revision rate did not differ by sex and was lower for age >65. In all, 24% of revisions occurred within the first 30 days after surgery; 63.5% occurred within year 1. Implant survivorship has improved annually since the device was introduced in 2009.

CONCLUSION: The survivorship rate with this implant is high and improving; the rate is somewhat higher than total hip replacement but lower than that of lumbar spine procedures.

Keywords: iFuse Implant System; revision; sacroiliac joint fusion; safety

References

  1. J Bone Joint Surg Am. 2000 Apr;82(4):457-76 - PubMed
  2. Spine J. 2005 Sep-Oct;5(5):520-8; discussion 529 - PubMed
  3. Spine (Phila Pa 1976). 2007 Feb 1;32(3):382-7 - PubMed
  4. J Bone Joint Surg Am. 2007 Oct;89 Suppl 3:144-51 - PubMed
  5. Spine J. 2009 May;9(5):374-86 - PubMed
  6. Spine (Phila Pa 1976). 2010 Mar 15;35(6):690-6 - PubMed
  7. Indian J Orthop. 2010 Apr;44(2):184-90 - PubMed
  8. J Bone Joint Surg Br. 2011 Mar;93(3):293-7 - PubMed
  9. J Bone Joint Surg Am. 2011 Nov 2;93(21):1979-86 - PubMed
  10. Spine J. 2012 Feb;12(2):89-97 - PubMed
  11. Open Orthop J. 2012;6:495-502 - PubMed
  12. J Neurosurg Sci. 2013 Dec;57(4):297-301 - PubMed
  13. Female Pelvic Med Reconstr Surg. 2013 Nov-Dec;19(6):333-8 - PubMed
  14. Ann Surg Innov Res. 2013 Oct 30;7(1):14 - PubMed
  15. Med Devices (Auckl). 2013 Dec 13;6:219-29 - PubMed
  16. Curr Urol Rep. 2014 Feb;15(2):380 - PubMed
  17. Spine J. 2014 Aug 1;14(8):1417-31 - PubMed
  18. Clin Orthop Relat Res. 2014 Jun;472(6):1711-7 - PubMed
  19. J Spinal Disord Tech. 2014 Oct;27(7):E234-40 - PubMed
  20. Clin Orthop Relat Res. 2014 Jun;472(6):1831-8 - PubMed
  21. Clin Orthop Relat Res. 2014 Jul;472(7):1999-2001 - PubMed
  22. JAMA. 2014 May 21;311(19):1956 - PubMed
  23. Med Devices (Auckl). 2014 Aug 28;7:299-304 - PubMed
  24. Open Orthop J. 2014 Oct 17;8:375-83 - PubMed
  25. Health Technol Assess. 2015 Jan;19(10):1-668, vii-viii - PubMed
  26. Spine J. 2016 Aug;16(8):909-16 - PubMed
  27. Int J Spine Surg. 2015 Jul 22;9:40 - PubMed
  28. Neurosurgery. 2015 Nov;77(5):674-90; discussion 690-1 - PubMed
  29. Global Spine J. 2016 May;6(3):257-69 - PubMed

Publication Types