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Compares treatment options for Lateral Malleolus Fracture
Official title A Study to Compare Two Different Managements After Ankle Surgery: Immediate and Delayed Weight-bearing.
ClinicalTrials.gov ID: NCT04429217
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join 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...
- Willingness and ability to participate in the trial
You likely can't join 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
See the full eligibility criteria
- 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...
- Willingness and ability to participate in the trial
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Lugano, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lugano, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.