Ankle Fractures, Inpatient, Orthopedic Procedures, Surgical Procedures
Conditions
Brief 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.
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.
Interventions
PROCEDUREAmbulatory care
The surgery is performed in ambulatory setting
PROCEDUREInpatient care
The surgery is performed during inpatient care
Sponsors
Christian Grundtvig Refstrup Rasmussen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
This study is a single center, prospective, assessor-blinded, randomized independent clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Foot and Ankle Outcomes Score | 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
| Measure | Time frame | Description |
|---|---|---|
| EQ-5D-5L questionnaire (5-level version) | 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. |
| Tegner activity scale | 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. |
| Adverse events | 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). |
| Patient satisfaction | 2, 6 and 12 weeks | Patient reported satisfaction. The patient is asked: 1. 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. 2. 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. |
| Bone union | 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. |
| Pain intensity measured on a 10 cm VAS scale | 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. |
| Ankle range of motion | 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. |
| Time to return to work | 2, 6 and 12 weeks | The time from surgery to end of sick leave measured in days. |
Countries
Denmark
Outcome results
None listed