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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 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.
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f2-mder-8-485: 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.

Mentions: The most common reasons for revision surgery were SM (38.4%) and SR (47.6%). The majority (86.8%) of revisions for SM occur within the first 6 months, while most (87.9%) revisions for SR occur after month 6. The 4-year probability of revision due to SM was 1.0%; the 4-year probability of revision due to SR was 1.94%. Revision rates for both conditions improved over time (P<0.0001 for SM, P=0.0118 for SR). In the more recent time period (2012–present, Figure 2), the cumulative 2-year risk of revision was ~2.5%; 0.9% for SM and 1.07% for SR.


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 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.
© Copyright Policy
Related In: Results  -  Collection

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

f2-mder-8-485: 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.
Mentions: The most common reasons for revision surgery were SM (38.4%) and SR (47.6%). The majority (86.8%) of revisions for SM occur within the first 6 months, while most (87.9%) revisions for SR occur after month 6. The 4-year probability of revision due to SM was 1.0%; the 4-year probability of revision due to SR was 1.94%. Revision rates for both conditions improved over time (P<0.0001 for SM, P=0.0118 for SR). In the more recent time period (2012–present, Figure 2), the cumulative 2-year risk of revision was ~2.5%; 0.9% for SM and 1.07% for SR.

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