Outpatient versus inpatient surgery for ankle fractures:A randomized controlled non-inferiority trial

Abstract

BACKGROUND: Growing evidence supports a shift from inpatient to outpatient surgical treatment for ankle fractures. The primary aim of this study was to investigate the effect of inpatient versus outpatient surgery of ankle fractures on patient-reported outcome utilizing the Foot and Ankle Outcome Score (FAOS) at 12 weeks following surgery. Secondary aims were to report patients' satisfaction, adverse events, pain, physical function, and bone healing between inpatient and outpatient treatment.PATIENTS AND METHODS: The study design was a non-inferiority randomized controlled, non-blinded trial with a two-groups. Patients were randomized 1:1 to outpatient or inpatient surgical treatment. The primary outcome was the FAOS at 12 weeks. Secondary outcomes included patients' satisfaction, health-related quality of life, intensity of pain, bone union, and adverse events.RESULTS: A total of 44 patients were randomized to inpatient surgery and 42 patients to outpatient surgery. The final follow-up at 12 weeks following surgery was completed by 69 patients (80 %). The mean age of patients was 49.2 (SD 16.9), ranging from 18 to 80. Female sex represented 44 % of patients. The primary analysis revealed no statistically significant difference in FAOS subscale scores between inpatient and outpatient surgery at the 12-week follow-up Adjusted mean difference: Pain: -0.8 (95 % CI -10.7-9.0); Symptoms: 2.7 (95 % CI -6.9-12.5); ADL: -4.7 (95 % CI -13.6-4.3); Sport/Rec: 2.9 (95 % CI -15.2-9.3); and QOL: -0.7 (95 % CI -11.8-10.3). Comparable results were observed for secondary outcomes.CONCLUSION: This study showed no statistical nor clinically significant difference in FAOS subscale scores between inpatient and outpatient surgery for ankle fractures 12 weeks following surgery. Furthermore, patients' satisfaction and adverse events were comparable between inpatient and outpatient surgery 12 weeks following treatment. Results indicated that outpatient surgery for ankle fractures is highly feasible for selected patients and may be considered as routine for clinical practice.</p