Outpatient Versus Inpatient Surgery for Ankle Fractures (OVISAF)

The FAOS is a patient-reported structure-specific questionnaire. Consisting of 5 subscales: pain, symptoms, activities of daily living (ADL), function in sport and recreation (Sport/Rec), and foot- and ankle-related quality of life (QOL). A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The result can be plotted as an outcome profile.

Patient reported satisfaction. The patient is asked: "Given your experience with the treatment, how likely is it that you would choose it again?" and the possible answers are preplanned, using a 5 point Lickert scale: Very likely, likely, either/or, unlikely, very unlikely. "Given your experience with the treatment, how likely is it, that you would recommend it to a relative or friend?" and the possible answers are preplanned, using a 5 point Lickert scale: Very likely, likely, either/or, unlikely, very unlikely.

General health will be assessed using EQ-5D-5L questionnaire (5-level version), both the descriptive index and the EQ-VAS. It consists of five dimensions: Mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and a self-rated health scale on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. An Eq5d-5L index of 1.0 indicated full health, 0 death, and -0.59 denoted a condition worse than death.

The Tegner activity scale is a 1-item instrument that assesses activity levels for sports (competitive or recreational) and occupational activities (light or heavy labor). It evaluates the patient's level of work and sports activity on an 11-level scale, with higher scores representing higher levels of physical activity.

Adverse events, defined as any negative or unwanted reactions to the two groups will be recorded. Based on previous reports we will focus on: infection, DVT and re-operation. Patients are continuously requested to report any suspicion of a potential AE. Patients will be asked about potential AEs. Furthermore, medical records will be checked at the primary endpoint (12 weeks) for all AEs occurring from inclusion until the 12 week follow-up. An AE is defined as any undesirable experience during follow-up leading to contact with the healthcare system (general practitioner or hospital). If an AE result in hospitalization, prolonged inpatient hospital care, result in re-surgery, or if an AE is life-threatening, result in death, permanent disability or damage, they will be categorized as serious adverse events (SAEs).

The time from surgery to end of sick leave measured in days.

Bone union, will be evaluated on standard AP and side X-rays of the fractured ankle. The evaluation of bone union will be defined as: i) visible callus formation, diminished no visible fracture line and no pain from the fracture site at weight-bearing and at clinical examination.

Development in pain will be recorded by patient-reported pain intensity measured on a 10 cm visual analogue scale (VAS) with endpoints "no pain" and "maximal pain" for the worst pain during the last 24 hours and resting pain.

Ankle range of motion. With the patient supine on an examination table the full range of passive motion in both ankle joints will be measured using a standard goniometer.