Frequency and Impact of Adverse Events in Patients Undergoing Surgery for End-stage Ankle Arthritis

Abstract

Category: Ankle Arthritis Introduction/Purpose: Patients seeking surgical treatment for ESAA have two primary treatment options: arthrodesis and arthroplasty. While there are comparative trials that address treatment options, neither the complication risk or the relative effectiveness is clearly established. The focus of this study was to report the magnitude of all AEs (as defined by DSMB) in the peri operative and early healing period after ankle surgery and evaluate the impact of these AEs on patient functional outcomes Methods: We report data from a multi-site prospective cohort study performed to compare ankle arthroplasty to ankle arthrodesis in the treatment of ESAA among six participating sites that required AE reporting under FDA required defintions. We compared the risk and impact of non-ankle AEs and ankle-specific AEs versus no AEs controlling for potential confounding factors including surgical procedure using multinomial logistic regression. We estimated differences in post-op functional outcomes by AE occurrence using linear mixed effects regression. Results: Among 517 patients who had surgery from 2012 to 2015 and completed the full baseline assessment, follow up was available in 494 (95%) patients. There were 628 reported AEs (477 in the arthroplasty group and 151 in the arthrodesis group), occurring in 261 (63%) arthroplasty patients and 67 (65%) arthrodesis patients. There were 50 (8%) ankle specific AEs. The odds ratio for the risk of an ankle specific AE and non-ankle specific AE versus no AE was 1.84, 95% CI (.85, 3.98) and .96, 95% CI (.57, 1.61), respectively, for those receiving arthrodesis compared to arthroplasty. Patients experiencing ankle-specific AEs had significantly less improvement in FAAM Sports and ADL subscores and worst pain outcomes; however, both groups improved significantly in all measures except mental health. Conclusion: Ankle specific AEs were infrequent and only weakly associated with surgical procedure (slightly more in arthrodesis). While patients improved in all functional outcomes except mental health, regardless of AE occurrence, ankle-specific AEs negatively impacted patient improvement compared to those with no AEs or a non-ankle AE.