CompletedNot Applicable

PRCT-study of Different Non-operative Treatment Protocols of ER-stress Negative Weber-B Unimalleolar Ankle Fractures.

Finland247 participantsStarted 2012-10

Plain-language summary

PRCT multicenter study to evaluate non-operative treatment protocols for treating ER-stress negative unimalleolar Weber-B type fibular fractures. Groups are: 1. 3 weeks in a removable splint 2. 3 weeks in a cast and 3. 6 weeks in a cast. Follow-up visits at 3, 6 and 12 weeks and after 1 and 2 years after injury. In each time X-rays laterally and mortise projections. Ankle functional outcome questionnaires: Olerud-Molander score, FAOS RAND-36 and VAS in follow up-visits 6 and 12 weeks and 1 and 2 year.

Who can participate

Age range

16 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: * Stable Weber-B type fibula fracture * ER-stress negative * 16 or over years old * Willingness to participate on study proved by a signature and date * Walking without aid before accident * Treatment started within 7 days from injury Exclusion Criteria: * Prior ankle fracture or significant fracture in the area of ankle or leg * Bilateral ankle fracture * Pathological fracture * Diabetes mellitus or an other significant periferial neuropathy * municipality of Residence in some else catchment area than Oulu university hospital or Tampere university hospital * Patient's understanding or co-operation inadequate

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

Olerud-Molander score

Timeframe: 1 year

Trial details

NCT IDNCT01758835

SponsorUniversity of Oulu

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-06

View on ClinicalTrials.gov More Lateral Malleolus Fractures trials