Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 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(®)

Affiliations

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

Daniel J Cher et al. Med Devices (Auckl). .

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.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Cumulative probability of all-cause revision after sacroiliac joint fusion using iFuse Implant System® by year of placement. Note: Shaded regions represent 95% confidence intervals.
Figure 2
Figure 2
Cumulative probability of revision after sacroiliac joint fusion using iFuse Implant System® for symptomatic malposition, symptomatic recurrence, and all causes for surgeries taking place between 2012 and 2014.

References

    1. Quality System Regulation; Complaint Files. Code of Federal Regulations, Title 21, Part 820. [Accessed July 1, 2014]. Available from: < http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR...=
    1. Medical Device Reporting. Code of Federal Regulations, Title 21, Part 803. [Accessed July 1, 2014]. Available from: < http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CF...<.
    1. Leopold SS. Editorial: when ‘safe and effective’ becomes dangerous. Clin Orthop. 2014;472:1999–2001. - PMC - PubMed
    1. Urban RM, Jacobs JJ, Tomlinson MJ, Gavrilovic J, Black J, Peoc’h M. Dissemination of wear particles to the liver, spleen, and abdominal lymph nodes of patients with hip or knee replacement. J Bone Joint Surg Am. 2000;82:457–476. - PubMed
    1. Rice NT, Hu Y, Slaughter JC, Ward RM. Pelvic mesh complications in women before and after the 2011 FDA public health notification. Female Pelvic Med Reconstr Surg. 2013;19:333–338. - PubMed

LinkOut - more resources