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

Cher DJ, Reckling WC, Capobianco RA - Med Devices (Auckl) (2015)

Bottom Line: The likelihood of revision surgery was calculated using the Kaplan-Meier life table approach.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.

View Article: PubMed Central - PubMed

Affiliation: Department of Clinical Affairs, SI-BONE, Inc. San Jose, CA, USA.

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.

No MeSH data available.


Related in: MedlinePlus

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.
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f1-mder-8-485: 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.

Mentions: The 4-year survival rate free from revision surgery was 96.46% (cumulative revision rate of 3.54%). Adjusting for the inability to match five revision cases to index surgeries, the adjusted 4-year survival rate was 96.40% (adjusted revision rate of 3.60%). The revision rate improved substantially over time (log-rank P<0.0001, Figure 1), with 1-year revision rates of 9.7%, 4.9%, 2.0%, 1.8%, 1.5%, and 1.4% during 2009, 2010, 2011, 2012, 2013, and 2014, respectively (P<0001). Because revision rates have fallen over time, the observed 4-year revision rate (3.55%) probably overestimates the actual current 4-year rate.


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

Cher DJ, Reckling WC, Capobianco RA - Med Devices (Auckl) (2015)

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.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4664491&req=5

f1-mder-8-485: 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.
Mentions: The 4-year survival rate free from revision surgery was 96.46% (cumulative revision rate of 3.54%). Adjusting for the inability to match five revision cases to index surgeries, the adjusted 4-year survival rate was 96.40% (adjusted revision rate of 3.60%). The revision rate improved substantially over time (log-rank P<0.0001, Figure 1), with 1-year revision rates of 9.7%, 4.9%, 2.0%, 1.8%, 1.5%, and 1.4% during 2009, 2010, 2011, 2012, 2013, and 2014, respectively (P<0001). Because revision rates have fallen over time, the observed 4-year revision rate (3.55%) probably overestimates the actual current 4-year rate.

Bottom Line: The likelihood of revision surgery was calculated using the Kaplan-Meier life table approach.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.

View Article: PubMed Central - PubMed

Affiliation: Department of Clinical Affairs, SI-BONE, Inc. San Jose, CA, USA.

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.

No MeSH data available.


Related in: MedlinePlus