Status:
RECRUITING
A Study to Compare Two Different Managements After Ankle Surgery: Immediate and Delayed Weight-bearing.
Lead Sponsor:
Ente Ospedaliero Cantonale, Bellinzona
Conditions:
Lateral Malleolus Fracture
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 in...
Detailed Description
The study population corresponds to the patients who may benefit from a post-operative rehabilitation protocol with immediate weight-bearing. Eligible lateral malleolar fractures are limited to Weber ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 2 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04429217
Start Date
April 28 2020
End Date
February 2 2028
Last Update
August 7 2025
Active Locations (1)
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1
Ente Ospedaliero Cantonale
Lugano, Switzerland, 6900