CompletedNot Applicable

Routine Versus on Demand Removal of the Syndesmotic Screw

Netherlands197 participantsStarted 2017-01

Plain-language summary

The objective of this trial is to demonstrate that the functional outcome of 'removal on demand' of the syndesmotic screw is non-inferior compared to routine removal of the syndesmotic screw in patients with an ankle fracture.

Who can participate

Age range18 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: * Over 17 years of age * Placement of a metallic syndesmotic screw for an unstable ankle fracture or an isolated syndesmotic injury * Syndesmotic screw placed within two weeks of the trauma * Being in such condition that one is able to possibly undergo a second procedure Exclusion Criteria: * ISS score \>15 * Injuries to the ipsi- and contralateral side which might hamper rehabilitation * Other medical conditions which hamper physical rehabilitation * Incomprehensive understanding of the Dutch language

What they're measuring

Functional outcome through the Olerud-Moland score

Timeframe: 1 year following initial treatment

Trial details

NCT IDNCT02896998

SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-05-01

View on ClinicalTrials.gov More Anke Fracture trials