Outpatient Versus Inpatient Surgery for Ankle Fractures (OVISAF)

Comparison Between Outpatient and Inpatient Surgically Treated 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.

Study Overview

• Status: Completed
• Conditions: Orthopedic Procedures; Ankle Fractures; Inpatient; Surgical Procedures
• Intervention / Treatment: Procedure: Ambulatory care; Procedure: Inpatient care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg Universitetshospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; The patient is discharged from the ER following X-ray, casting, charts. The patient is contacted when surgery is scheduled, and this is performed in a ambulatory setting	Procedure: Ambulatory care; The surgery is performed in ambulatory setting
Active Comparator: Standard; The patient is admitted from the ER, surgery is performed when possible in regards to surgical capacity and swelling. Discharged when mobilised with cast.	Procedure: Inpatient care; The surgery is performed during inpatient care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foot and Ankle Outcomes Score	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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	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, 6 and 12 weeks
EQ-5D-5L questionnaire (5-level version)	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.	2, 6 and 12 weeks
Tegner activity scale	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.	12 weeks
Adverse events	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).	2 days, 2, 6 and 12 weeks
Time to return to work	The time from surgery to end of sick leave measured in days.	2, 6 and 12 weeks
Bone union	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.	6 and 12 weeks
Pain intensity measured on a 10 cm VAS scale	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.	2 days, 2, 6 and 12 weeks
Ankle range of motion	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.	6 and 12 weeks

Collaborators and Investigators

• Sponsor: Christian Grundtvig Refstrup Rasmussen
• Investigators: Principal Investigator: Christian GR Rasmussen, MD, Department of Orthopedic Surgery

Publications and helpful links

General Publications

• Rasmussen CG, Larsen P, Pedersen C, Elsoe R. Outpatient versus inpatient surgery for ankle fractures - a protocol for a randomised controlled trial. Dan Med J. 2025 Jun 26;72(7):A10240746. doi: 10.61409/A10240746.

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2022
• Primary Completion (Actual): March 20, 2025
• Study Completion (Actual): March 20, 2025

Study Registration Dates

• First Submitted: May 20, 2022
• First Submitted That Met QC Criteria: May 24, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Estimated): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Ankle Injuries; Ankle Fractures; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Hospitalization; Ambulatory Care
• Other Study ID Numbers: N-20220012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: A detailed statistical analysis plan will be made publicly available before the last patient is included in the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No