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.
Procedure: Removal on demand of the syndesmotic screw
Procedure: Routine removal of fhe syndesmotic screw
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Full eligibility criteria for NCT02896998
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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
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
All locations for NCT02896998
Academic Medical Center
Amsterdam, Noord-Holland, Netherlands, 1105AZ
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View full eligibility
Tris trial is registered with FDA with number: NCT02896998. The sponsor of the trial is Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) and it is looking for 193 volunteers for the current phase.
Official trial title: Routine Versus on Demand Removal of the Syndesmotic Screw
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