RESUMO
BACKGROUND: End-stage ankle osteoarthritis causes severe pain and disability. There are no randomized trials comparing the 2 main surgical treatments: total ankle replacement (TAR) and ankle fusion (AF). OBJECTIVE: To determine which treatment is superior in terms of clinical scores and adverse events. DESIGN: A multicenter, parallel-group, open-label randomized trial. (ISRCTN registry number: 60672307). SETTING: 17 National Health Service trusts across the United Kingdom. PATIENTS: Patients with end-stage ankle osteoarthritis, aged 50 to 85 years, and suitable for either procedure. INTERVENTION: Patients were randomly assigned to TAR or AF surgical treatment. MEASUREMENTS: The primary outcome was change in Manchester-Oxford Foot Questionnaire walking/standing (MOXFQ-W/S) domain scores between baseline and 52 weeks after surgery. No blinding was possible. RESULTS: Between 6 March 2015 and 10 January 2019, a total of 303 patients were randomly assigned; mean age was 68 years, and 71% were men. Twenty-one patients withdrew before surgery, and 281 clinical scores were analyzed. At 52 weeks, the mean MOXFQ-W/S scores improved for both groups. The adjusted difference in the change in MOXFQ-W/S scores from baseline was -5.6 (95% CI, -12.5 to 1.4), showing that TAR improved more than AF, but the difference was not considered clinically or statistically significant. The number of adverse events was similar between groups (109 vs. 104), but there were more wound healing issues in the TAR group and more thromboembolic events and nonunion in the AF group. The symptomatic nonunion rate for AF was 7%. A post hoc analysis suggested superiority of fixed-bearing TAR over AF (-11.1 [CI, -19.3 to -2.9]). LIMITATION: Only 52-week data; pragmatic design creates heterogeneity of implants and surgical techniques. CONCLUSION: Both TAR and AF improve MOXFQ-W/S and had similar clinical scores and number of harms. Total ankle replacement had greater wound healing complications and nerve injuries, whereas AF had greater thromboembolism and nonunion, with a symptomatic nonunion rate of 7%. PRIMARY FUNDING SOURCE: National Institute for Health and Care Research Heath Technology Assessment Programme.
Assuntos
Artroplastia de Substituição do Tornozelo , Osteoartrite , Masculino , Humanos , Idoso , Feminino , Artroplastia de Substituição do Tornozelo/efeitos adversos , Artroplastia de Substituição do Tornozelo/métodos , Articulação do Tornozelo/cirurgia , Tornozelo/cirurgia , Medicina Estatal , Resultado do Tratamento , Artrodese/efeitos adversos , Artrodese/métodosRESUMO
OBJECTIVE: To describe the successful implementation of an in situ simulation program to diagnose and correct latent safety threats in a level 4 neonatal intensive care unit (NICU) to mitigate a methicillin-resistant Staphylococcus aureus (MRSA) outbreak. STUDY DESIGN: An investigational report describes a simulation intervention that occurred during a 4-month MRSA outbreak in a single-center, 46-bed, newly renovated level 4 NICU. The simulation program was developed for all NICU providers in which they were exposed to a 30-minute in situ human simulation intervention that included education, evaluation, and debriefing to resolve perceived or observed latent safety threats. The primary study outcome was improved hand hygiene compliance and an enhanced estimate of the culture of safety during a 6-month period. RESULTS: A total of 99 healthcare providers including physicians, nurses, respiratory therapists, and environmental service workers completed the course. Before the simulation intervention, there were 18 patients colonized or infected with a single MRSA clone; after the intervention, there were no new episodes of colonization or infection. CONCLUSIONS: An in situ, simulation-based intervention can counter threats to patient safety related to workflow and lapses in infection control practices and improve patient outcomes.