A Study to Compare Two Different Managements After Ankle Surgery: Immediate and Delayed Weight-bearing.
Recruiting now · Not applicable
Conditions studied: Lateral Malleolus Fracture
In brief
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.
Key facts
- Study ID
- NCT04429217
- Run by
- Ente Ospedaliero Cantonale, Bellinzona
- People needed
- 100
- Starts
- 2020-04-28
- Expected to finish
- 2028-02-02
- Last updated by the study team
- 2025-08-07
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Ente Ospedaliero Cantonale — Lugano, Switzerland (enrolling)
Full record on ClinicalTrials.gov
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