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Completed

NCT Number: NCT05389436

Outpatient Versus Inpatient Surgery for Ankle Fractures

This study is a single center randomized controlled trail in which we compare outpatient and inpatient patients with an ankle fracture requiring surgical treatment.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg Universitetshospital

Aalborg, 9000, Denmark

About this study

This study is a single center randomized controlled trail in which we compare outpatient and inpatient patients with an ankle fracture requiring surgical treatment.

Primary outcome: The primary objective of this study is to compare the 12-weeks patient reported Foot and Ankle Outcome Score (FOAS).

Secondary outcomes: Multiple other analysis are planned, but being secondary, they are hypothesis generating. They will include, but are not limited to, cross-over, unscheduled contacts, adverse events, pain, general health, time to return to work and socio-economic consequences between the two groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ankle fracture indicating surgical treatment.
  • Fracture stable in lower leg cast.
  • Patient 18 years or older.
  • Patient is able to ambulate with walking aid, and perform ADL at home.

Exclusion criteria

  • Impaired physical, mental or social capacity incapable of participating in study.
  • Incapable of reading or understanding Danish.
  • Patient does not wich to participate.
  • Concurrent major fracture to lower extremity (ipsi- and/or contralateral)
  • Patholocigal fracture
  • ASA score 3 or higher.
  • Pregnancy.
  • Open fracture.
  • Infectious disease requiring isolation.

Treatment and study plan

Ambulatory care

Procedure

The surgery is performed in ambulatory setting

Inpatient care

Procedure

The surgery is performed during inpatient care

Primary outcomes

  1. Foot and Ankle Outcomes Score

    Time frame: 12 weeks

    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.

Secondary outcomes

  1. Patient satisfaction

    Time frame: 2, 6 and 12 weeks

    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.
  2. EQ-5D-5L questionnaire (5-level version)

    Time frame: 2, 6 and 12 weeks

    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.

  3. Tegner activity scale

    Time frame: 12 weeks

    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.

  4. Adverse events

    Time frame: 2 days, 2, 6 and 12 weeks

    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).

  5. Time to return to work

    Time frame: 2, 6 and 12 weeks

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

  6. Bone union

    Time frame: 6 and 12 weeks

    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.

  7. Pain intensity measured on a 10 cm VAS scale

    Time frame: 2 days, 2, 6 and 12 weeks

    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.

  8. Ankle range of motion

    Time frame: 6 and 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Christian Grundtvig Refstrup Rasmussen

Other

Registry information

Official study title

Comparison Between Outpatient and Inpatient Surgically Treated Ankle Fractures

Acronym: OVISAF

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 25, 2022
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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