A Study to Compare Two Different Managements After Ankle Surgery: Immediate and Delayed Weight-bearing.
Immediate vs Delayed Weight-bearing After Surgical Treatment of Malleolar Fractures: a Randomized Controlled Trial
Ente Ospedaliero Cantonale, Bellinzona
100 participants
Apr 28, 2020
INTERVENTIONAL
Conditions
Summary
The investigators will compare two types of rehabilitation in patients who undergo a surgery for treatment of malleolar fractures: immediate complete weight-bearing and delayed weight-bearing. The investigators want to evaluate if the immediate complete weight-bearing can improve and hasten the functional outcome of the ankle without increasing the risk of complications.
Eligibility
Inclusion Criteria5
- Male and female adults
- Age ranging from 18 to 70 years, included
- Signed Informed Consent
- Ankle fracture requiring surgical management classified as:1- Weber A fracture pattern (AO 44.A1, 44.A2, 44.A3) with or without association with a medial or posterior lesion/fracture or 2- Weber B fracture pattern (AO 44.B1, 44.B2, 44.B3) with or without association with a medial or posterior lesion/fracture
- Willingness and ability to participate in the trial
Exclusion Criteria10
- Weber C fracture pattern
- Bilateral fractures or fractures in other locations
- Maissoneauve associated lesion
- Body Mass Index \< 18.5 and ≥ 30
- Metabolic diseases influencing fracture healing processes
- Medical comorbidities precluding operative intervention
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, general physical problem of the participant, etc.
- Inability or contraindications to undergo the investigated intervention
- Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
- Pregnant women
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Interventions
Patients randomized to the experimental post-operative rehabilitation intervention will undergo to immediate complete weight-bearing starting immediately after surgery. Immediate complete weight-bearing consists in the possibility to undergo all the everyday activities without limiting weight-bearing and without the use of walking aids. During the rehabilitation period, patients will wear an ankle brace (VACOankle® OPED); this will ensure the safety of the early recovery phases, protecting from dangerous movements while allowing the mobilization in the healthy range of movement.
Patients randomized to the control post-operative rehabilitation intervention will undergo to delayed weight-bearing starting at 6-weeks post-operatively. Delayed weight-bearing consists in the limitation of the weight-bearing to 20-30% of patient's total weight using crutches for the first 6 weeks after surgery. During the rehabilitation period, patients will wear an ankle brace (VACOankle® OPED).
Locations(1)
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NCT04429217