Norvell Daniel C, Shofer Jane B, Hansen Sigvard T, Davitt James, Anderson John G, Bohay Donald, Coetzee J Chris, Maskill John, Brage Michael, Houghton Michael, Ledoux William R, Sangeorzan Bruce J
1 Spectrum Research, Tacoma, WA, USA.
2 VA Puget Sound Health Care System, Seattle, WA, USA.
Foot Ankle Int. 2018 Sep;39(9):1028-1038. doi: 10.1177/1071100718776021. Epub 2018 May 31.
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.
This was a multisite prospective cohort study to compare ankle arthroplasty to ankle arthrodesis in the treatment of ESAA among 6 participating sites. We compared the risk and impact of nonankle AEs and ankle-specific AEs versus no AEs controlling for potential confounding factors, including operative procedure using multinomial logistic regression. We estimated differences in postoperative 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.
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 versus the arthroplasty group, odds ratio (OR) 1.84, 95% confidence interval (CI, 0.85, 3.98). The OR for the risk of non-ankle-specific AE versus no AE was 0.96, 95% CI (0.57, 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 activities of daily living (ADL) subscores and worst pain outcomes; however, both groups improved significantly in all measures except mental health.
Ankle-specific AEs were infrequent and only weakly associated with operative procedure. Although 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 nonankle AE. The logistical effort and cost of tracking nonankle AEs does not seem to be justified.
Level II, prospective comparative study.
本研究总结了终末期踝关节关节炎（ESAA）手术后不良事件（AE）的发生频率及其功能影响，以辅助决策。
这是一项多中心前瞻性队列研究，在6个参与地点比较踝关节置换术与踝关节融合术治疗ESAA的效果。我们比较了非踝关节AE和踝关节特异性AE与无AE的风险及影响，并通过多项逻辑回归控制潜在混杂因素，包括手术方式。我们使用线性混合效应回归估计AE发生对术后功能结局的差异。在517例行踝关节关节炎手术并完成完整基线评估的患者中，494例（95%）患者有随访评分。
共报告628例AE（置换组477例，融合组151例）。这些AE发生在261例（63%）置换术患者和67例（65%）融合术患者中。有50例（8%）踝关节特异性AE。融合组踝关节特异性AE的风险略高于置换组，优势比（OR）为1.84，95%置信区间（CI，0.85，3.98）。与置换术相比，接受融合术患者非踝关节特异性AE与无AE的风险OR为0.96，95%CI（0.57，1.61）。与无AE的患者相比，发生踝关节特异性AE的患者在足踝能力测量运动和日常生活活动（ADL）子评分方面改善明显较少，疼痛结局更差；然而，除心理健康外，两组在所有测量指标上均有显著改善。
踝关节特异性AE不常见，且与手术方式仅存在微弱关联。尽管除心理健康外，所有功能结局均有改善，无论AE是否发生，但与无AE或非踝关节AE的患者相比，踝关节特异性AE对患者改善有负面影响。追踪非踝关节AE的后勤工作和成本似乎不合理。
二级，前瞻性比较研究。
