Routine Versus on Demand Removal of the Syndesmotic Screw
NCT ID: NCT02896998
Last Updated: 2020-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
197 participants
INTERVENTIONAL
2017-01-31
2020-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control group
The syndesmotic screw will routinely be removed 8 - 12 weeks following placement of the screw
Routine removal of fhe syndesmotic screw
The syndesmotic screw will routinely be removed 8 - 12 weeks following placement of the screw
Intervention
The syndesmotic screw will only be removed in case of symptomatic implants (e.g. implants causing pain or restricted range of motion)
Removal on demand of the syndesmotic screw
The syndesmotic screw will only be removed in case of a symptomatic implant (e.g. implant causing pain or restricted range of motion)
Interventions
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Removal on demand of the syndesmotic screw
The syndesmotic screw will only be removed in case of a symptomatic implant (e.g. implant causing pain or restricted range of motion)
Routine removal of fhe syndesmotic screw
The syndesmotic screw will routinely be removed 8 - 12 weeks following placement of the screw
Eligibility Criteria
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Inclusion Criteria
* 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
* Injuries to the ipsi- and contralateral side which might hamper rehabilitation
* Other medical conditions which hamper physical rehabilitation
* Incomprehensive understanding of the Dutch language
18 Years
ALL
No
Sponsors
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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J.C. Goslings
Professor
Locations
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Academic Medical Center
Amsterdam, North Holland, Netherlands
Countries
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References
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Dingemans SA, Birnie MFN, Sanders FRK, van den Bekerom MPJ, Backes M, van Beeck E, Bloemers FW, van Dijkman B, Flikweert E, Haverkamp D, Holtslag HR, Hoogendoorn JM, Joosse P, Parkkinen M, Roukema G, Sosef N, Twigt BA, van Veen RN, van der Veen AH, Vermeulen J, Winkelhagen J, van der Zwaard BC, van Dieren S, Goslings JC, Schepers T. Routine versus on demand removal of the syndesmotic screw; a protocol for an international randomised controlled trial (RODEO-trial). BMC Musculoskelet Disord. 2018 Jan 31;19(1):35. doi: 10.1186/s12891-018-1946-5.
Other Identifiers
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METC2016_197
Identifier Type: -
Identifier Source: org_study_id
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