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This study is a single center randomized controlled trail in which we compare outpatient and inpatient patients with an ankle fracture requiring surgical treatment.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambulatory care | Procedure | The surgery is performed in ambulatory setting |
| |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | Patient reported satisfaction. The patient is asked:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian GR Rasmussen, MD | Department of Orthopedic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg Universitetshospital | Aalborg | 9000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40600684 | Derived | 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. |
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A detailed statistical analysis plan will be made publicly available before the last patient is included in the study.
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| ID | Term |
|---|---|
| D064386 | Ankle Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D016512 | Ankle Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| D000553 | Ambulatory Care |
| D006760 | Hospitalization |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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This study is a single center, prospective, assessor-blinded, randomized independent clinical trial
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Due to the nature of this study the patient, surgeon and care providers can not be blinded. The outcome assessor will be blinded with regards to the two treatment groups.
| Inpatient care |
| Procedure |
The surgery is performed during inpatient care |
|
| 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 |