Frequency and impact of adverse events in patients undergoing surgery for end stage ankle arthritis
Daniel C. Norvell, Ph.D.,1 Jane B. Shofer, M.S.,2 Sigvard T. Hansen, M.D.,3 James Davitt, M.D.,5 John G. Anderson, M.D.,4 Donald Bohay, M.D.,4 J. Chris Coetzee, M.D.,6 John Maskill, M.D.,4 Michael Brage, M.D.,3 Michael Houghton, M.D.,7 William R. Ledoux, Ph.D.,2,3,8 and Bruce J. Sangeorzan, M.D.2,3Ankle
Background
This study summarized the frequency and functional impact of adverse events (AEs) that occur after surgery for End-stage ankle arthritis (ESAA) to inform decision making.
Methods
This was a multi-site prospective cohort study to compare ankle arthroplasty to ankle arthrodesis in the treatment of ESAA among six participating sites. 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. Among 517 patients who had surgery for ankle arthritis and completed the full baseline assessment, follow up scores were available in 494 (95%) patients.
Results
There were a total of 628 reported AEs (477 in the arthroplasty group and 151 in the arthrodesis group). These occurred in 261 (63%) arthroplasty patients and 67 (65%) arthrodesis patients. There were 50 (8%) ankle specific AEs. The risk of an ankle specific AE was slightly higher in the arthrodesis group vs the arthroplasty group, odds ratio 1.84, 95% CI (.85, 3.98). The odds ratio for the risk of non-ankle specific AE versus no AE was .96, 95% CI (.57, 1.61) for those receiving arthrodesis compared to arthroplasty. Compared to patients with no AEs, those experiencing ankle-specific AEs had significantly less improvement in Foot and Ankle Ability Measure Sports and ADL subscores and worst pain outcomes; however, both groups improved significantly in all measures except mental health.
Conclusions
Ankle specific AEs were infrequent and only weakly associated with surgical procedure. 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. The logistical effort and cost of tracking non-ankle AEs does not seem to be justified.
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