Clinical Data
Safety, 4-Year Revision Rate (Cher - MDER 2015)
Implant Survivorship Analysis after Minimally Invasive Sacroiliac Joint Fusion using the iFuse Implant System
Cher DJ, Reckling WC, Capobianco RA. Med Devices (Auckl). 2015;8:485-92.
DOI: 10.2147/MDER.S94885. PMCID: PMC4664491
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