1. In patients with end-stage ankle osteoarthritis, no difference was observed in outcomes between total ankle replacement (TAR) and ankle fusion (AF) surgeries.
2. There were no significant differences in the rate of adverse events in patients who received ART compared to AF surgeries.
Level of evidence assessment: 1 (Excellent)
Summary of the study: Surgical procedures are indicated for patients with severe ankle osteoarthritis who have failed six months of nonoperative management. ART and AF are the main surgical treatments for ankle OA. This randomized controlled trial is the first to compare clinical effectiveness and adverse event rates between ART and AF for patients with end-stage ankle osteoarthritis. Patients were followed for one year after surgery. TAR and FA were compared based on the primary outcome of 52-week change in Manchester-Oxford Foot Questionnaire (MOXFQ-W/S) walking/standing domain score and secondary outcomes of 26- and 52 weeks of MOXFQ-W/S, activities of daily living and quality of life. While both ART and FA patients had improved clinical outcomes measured by MOXFQ-W/S, there were no significant differences in the magnitude of improvement between the groups. There was greater improvement in activities of daily living, as measured by the Foot and Ankle Ability Measure-Activities of Daily Living (FAAM-ADL), in the TAR group compared to the AF group. There were no significant differences in the overall rate of adverse events between the groups. As a limitation, long-term results could not be assessed, as the observation period was only 52 weeks. The type of ART (mobile or fixed support) or FA (open or arthroscopic) was not specified, which may introduce unintended heterogeneity in the treatment groups.
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In depth [randomized controlled trial]: In this randomized controlled trial, the clinical outcomes and safety of ART and AF were compared in patients aged 50-85 years with end-stage ankle osteoarthritis (n=303). Patients were randomized 1:1 to receive ART (n=152) or AF (n=151) and followed for 52 weeks. Patient outcomes were measured preoperatively and at 26 and 52 weeks postoperatively using the MOXFQ-W/S, MOXFQ pain and social interaction, and FAAM-ADL domains. For the primary outcome of the MOXFQ-W/S score, the TAR and AF groups improved by an average of 49.9 and 44.4 points, respectively, between baseline and 52 weeks postoperatively. This change was not significantly different between the groups. For the secondary outcome, the ART group demonstrated greater improvements over 52 weeks in FAAM-ADL scores compared to the AF group (difference, 6.16; 95% confidence interval [CI], 1.54 to 10.78). In terms of safety, 27 (18%) and 36 (24%) patients in the ART and AF groups, respectively, experienced at least one serious adverse event, while 82 (54%) and 80 (53%), respectively , experienced at least one adverse event. Wound healing complications (13% and 6% in the TAR and AF groups, respectively) and nerve damage (4% and <1%, respectively) were more common in the TAR group. Thromboembolic events were less frequent in the ART group than in the AF group (3% and 5%, respectively). This is the first study to assess the clinical outcomes and safety of ART and AF and may inform patients and physicians in their clinical decision-making.
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