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 range16 Years

SexALL

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

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