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Routine Versus on Demand Removal of the Syndesmotic Screw (NCT02896998)

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
    The syndesmotic screw will only be removed in case of a symptomatic implant (e.g. implant causing pain or restricted range of motion)
    • Procedure: Routine removal of fhe syndesmotic screw
      The syndesmotic screw will routinely be removed 8 - 12 weeks following placement of the screw
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      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

      1 locations

      Netherlands (1)
      • Academic Medical Center
        recruiting
        Amsterdam, Noord-Holland, Netherlands, 1105AZ
      Status:
      recruiting
      Type:
      Interventional
      Phase:
      -
      Start:
      31 August, 2016
      Updated:
      10 September, 2016
      Participants:
      193
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