Outpatient versus inpatient surgery for ankle fractures - a protocol for a randomised controlled trial.

Abstract

Introduction: In recent years, outpatient surgical treatment for ankle fractures has been introduced for selected fracture types and patients with a low degree of comorbidity. Limited evidence is available to guide the choice between inpatient and outpatient care for ankle fractures. This randomised controlled trial aims to investigate the effect of inpatient versus outpatient surgery of ankle fractures on patient-reported outcomes at 12 weeks.

Methods: This study is a single-centre non-inferiority randomised controlled trial investigating outpatient care for surgically treated ankle fractures. A total of 86 patients will be included in the study and randomised 1:1 to either outpatient or inpatient care. The primary outcome is the Foot and Ankle Outcome Score at three months after surgery. Secondary outcomes will include patient satisfaction, pain, physical function and adverse events.

Conclusions: Conducting a randomised controlled trial investigating inpatient versus outpatient surgery for ankle fractures on both patient-reported outcomes, patient satisfaction, adverse events, pain, function and bone healing will provide evidence to guide future recommendations in the planning of surgical treatment for ankle fractures.

Funding: The study is partially funded by Helsefonden and the North Denmark Region.

Trial registration: The study was pre-registered on Clinicaltrials.gov ID: NCT05389436, 20 May 2022.