Ankle FracturesOVISAFNCT05389436
Outpatient Versus Inpatient Surgery for Ankle Fractures
A study testing Ambulatory care and Inpatient care in people with Ankle Fractures and Orthopedic Procedures, run by Christian Grundtvig Refstrup Rasmussen at 1 site in Denmark.
Trial summary
This study is a single center randomized controlled trail in which we compare outpatient and inpatient patients with an ankle fracture requiring surgical treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Fractures, Orthopedic Procedures, Surgical Procedures
- What is being tested?
- Ambulatory care and Inpatient care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteDenmark
- Study dates
- 23 May 2022to 20 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Pregnancy.
- Open fracture.
- Infectious disease requiring isolation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Ankle Fractures, Orthopedic Procedures, Surgical Procedures, Inpatient
- Being tested
- Ambulatory care, Inpatient care
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory careProcedure or surgery
The surgery is performed in ambulatory setting
Inpatient careProcedure or surgery
The surgery is performed during inpatient care
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Ambulatory care |
| Standard | Active comparator | The patient is admitted from the ER, surgery is performed when possible in regards to surgical capacity and swelling. Discharged when mobilised with cast. Receives: Procedure: Inpatient care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 2 days, 2, 6 and 12 weeks
Time to return to work
The time from surgery to end of sick leave measured in days.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start23 May 2022
- Primary completion20 Mar 2025
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a single center, prospective, assessor-blinded, randomized independent clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christian Grundtvig Refstrup Rasmussen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christian Grundtvig Refstrup Rasmussen, Aalborg University Hospital
- Investigators
- Christian GR Rasmussen, MD, Principal investigator, Department of Orthopedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389436
- Sponsor's protocol ID
- N-20220012
- Acronym
- OVISAF
- Status last verified
- Dec 2025
- First submitted
- 20 May 2022
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A detailed statistical analysis plan will be made publicly available before the last patient is included in the study.
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.
PubMed 40600684
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Outpatient and Inpatient Surgically Treated Ankle Fractures
- ClinicalTrials.gov ID
- NCT05389436
- Acronym / sponsor ID
- OVISAF / N-20220012
- Conditions
- Ankle Fractures, Orthopedic Procedures, Surgical Procedures, Inpatient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Christian Grundtvig Refstrup RasmussenUniversity, hospital or other
- Study start
- 23 May 2022 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single center randomized controlled trail in which we compare outpatient and inpatient patients with an ankle fracture requiring surgical treatment.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a single center, prospective, assessor-blinded, randomized independent clinical trial
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: Ambulatory careThe 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 |
| Standard | Active comparator | Procedure: Inpatient careThe patient is admitted from the ER, surgery is performed when possible in regards to surgical capacity and swelling. Discharged when mobilised with cast. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambulatory careThe surgery is performed in ambulatory setting | Procedure or surgery | Experimental |
| Inpatient careThe surgery is performed during inpatient care | Procedure or surgery | Standard |
Primary outcome
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.
8 secondary outcomes
Patient satisfaction
Time frame: 2, 6 and 12 weeks
EQ-5D-5L questionnaire (5-level version)
Time frame: 2, 6 and 12 weeks
Tegner activity scale
Time frame: 12 weeks
Adverse events
Time frame: 2 days, 2, 6 and 12 weeks
Time to return to work
Time frame: 2, 6 and 12 weeks
Bone union
Time frame: 6 and 12 weeks
Pain intensity measured on a 10 cm VAS scale
Time frame: 2 days, 2, 6 and 12 weeks
Ankle range of motion
Time frame: 6 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Derived from this study: PubMed 40600684Rasmussen 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.
- Individual participant dataSharing planned: No. A detailed statistical analysis plan will be made publicly available before the last patient is included in the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian GR Rasmussen, MD principal investigator
Department of Orthopedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambulatory care and Inpatient care in people with Ankle Fractures and Orthopedic Procedures, run by Christian Grundtvig Refstrup Rasmussen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot and Ankle Outcomes Score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05389436, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.