RecruitingNot Applicable

A Study to Compare Two Different Managements After Ankle Surgery: Immediate and Delayed Weight-bearing.

Switzerland100 participantsStarted 2020-04-28

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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 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 Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

change from day 1 after surgery in subjective functional ankle recovery on the Olerud-Molander Ankle Score at week 6

Timeframe: baseline and week 6

Trial details

NCT IDNCT04429217

SponsorEnte Ospedaliero Cantonale, Bellinzona

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-02-02

Contact for this trial

Enrique Adrian Testa, MD

+41 (0)91 811 69 31 enriqueadrian.testa@eoc.ch

View on ClinicalTrials.gov More Lateral Malleolus Fracture trials