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The treatment of stable ankle fractures: Brace versus Cast immobilization


- candidate number16837
- NTR NumberNTR4469
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-mrt-2014
- Secondary IDsNL41177.098.12 
- Public TitleThe treatment of stable ankle fractures: Brace versus Cast immobilization
- Scientific TitleThe treatment of stable ankle fractures: Brace versus Cast immobilization
- ACRONYMGiBra
- hypothesisThis is study is to examine if a functional brace in the treatment of Unimalleolar Weber-B fracture results in a higher Olerud and Molander Score, less pain, better comfort, greater range of motion.
- Healt Condition(s) or Problem(s) studiedAnkle fracture, Weber B
- Inclusion criteriaPatients with a stable ankle fracture (type Weber B and less than 2 mm dislocation), between the age of 18 and 75 years old
- Exclusion criteria- Multiple fractures - Mental handicap - Patients not living in the right region, i.e. follow up takes place in a different medical centre. - Patients who do not speak Dutch fluently
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2013
- planned closingdate31-jan-2015
- Target number of participants100
- InterventionsAt 1 week post fracture the patient will return to the clinic. If he/she is willing to participate in the trial the randomization will take place. Group 1 consists of patients treated with cast immobilization for a period of 5 weeks. Group 2 consists of patients treated with a functional ankle brace for a period of 5 weeks. Week 1: Olerud & Molander Ankle Score Pain level using a Visual Analogue Scale Patient comfort using a Visual Analogue Scale Dislocation of the fracture using radiographs Euroqol-5D questionnaire Week 3: Olerud & Molander Ankle Score Pain level using a Visual Analogue Scale Patient comfort using a Visual Analogue Scale Dislocation of the fracture using radiographs Euroqol-5D questionnaire Week 6: Olerud & Molander Ankle Score Pain level using a Visual Analogue Scale Patient comfort using a Visual Analogue Scale Range of Motion Dislocation of the fracture using radiographs Euroqol-5D questionnaire Week 12: Olerud & Molander Ankle Score Pain level using a Visual Analogue Scale Range of Motion Euroqol-5D questionnaire Week 26: Olerud & Molander Ankle Score Pain level using a Visual Analogue Scale Range of motion Euroqol-5D questionnaire AAOS-score Week 52: Olerud & Molander Ankle Score Pain level using a Visual Analogue Scale Range of motion Euroqol-5D questionnaire AAOS-score The presence of arthrosis using radiographs (Ankle Osteoarthritis Scale)
- Primary outcomePrimary outcome is the Olerud & Molander Score at 6 weeks.
- Secondary outcome- pain - comfort of cast / brace - Range of motion - long term function (using the AAOS foot and ankle score) - health related quality of life using the EQ5D - fracture dislocation - presence of osteoarthritis at 1 year
- Timepoints1 week 3 weeks 6 weeks 12 weeks 26 weeks 1 year
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. N.L. Weil
- CONTACT for SCIENTIFIC QUERIESDrs. N.L. Weil
- Sponsor/Initiator Medisch Centrum Haaglanden, Bronovo Hospital
- Funding
(Source(s) of Monetary or Material Support)
Medical Center Haaglanden
- Publications
- Brief summaryAnkle fractures are commonly seen on emergency departments of hospitals. They represent about 10% of all fractures and the incidence is expected to increase in the following years. n the case of an ankle fracture, the fibula (lateral malleolus) and/or the tibia (medial and/or posterior malleolus) can be injured. Furthermore, there can be ligament injury (mainly the syndesmosis between tibia and fibula en the deltoid ligament are of important value). The degree of osseous and/or ligament injury determines if the fracture is stable or unstable. In general, stable fractures are treated non-operatively (conservatively) and unstable fractures are treated operatively. The current treatment of stable ankle fractures in the Netherlands and most other Western European countries consist of 6 weeks cast immobilization: a below-the-knee plaster cast for 1-2 weeks non-weight bearing, followed by a fiberglass short leg walking cast for the next 4-5 weeks, bearing weight within the limits of pain. Disadvantages of this treatment are that after cast immobilization some stiffness in the ankle joint may develop, atrophy of the calf muscle occurs and there might be an increased risk of developing osteoporosis. In some countries, including Switzerland, stable ankle fractures are often treated with a functional brace. Some previous studies indicate that this functional treatment prevents fracture dislocation as well as cast immobilization does, although it results in better clinical outcome and more comfort. A recent Cochrane Review (2009) described that there is limited evidence that the use of a removable type of immobilization and performing exercises during the immobilization period result in a better outcome. They also indicate that more clinical studies are necessary to support the current evidence. Future trials need to be adequately designed, outcome measures and endpoints need to be clear and they need to be adequately powered so that the results can be conclusive. The aim of this study is to examine if a functional brace in the treatment of Unimalleolar Weber-B fracture results in a higher Olerud and Molander Score, less pain, better comfort, greater range of motion. This stydt is a multicenter, prospective clinical trial in Medical Center Haaglanden (The Hague) and Bronovo Hospital (The Hague). All patients presenting at the emergency department with a stable ankle fracture will initially be treated with cast immobilization, the current treatment. Patients that meet the inclusion criteria will be informed about the study at the emergency department and they get an information letter. One week after visit to the emergency department there will be a check by the trauma-surgeon of the fracture by an ankle X-ray. If the fracture shows to be stable, they will be included in the study and randomization takes place under patients who are willing to participate in the trial. Group 1 will receive the current treatment with cast immobilization for a period of 5 weeks (non-weight bearing for 2 weeks and 3 weeks bearing weight within the limits of pain). Patients will be reviewed at 1 week, 3 weeks, 6 weeks, 12 weeks, 26 weeks and 52 weeks. After which both groups will be analyzed using SPSS version 20 or higher.
- Main changes (audit trail)
- RECORD14-mrt-2014 - 14-apr-2014


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