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Completed

NCT Number: NCT02896998

Routine Versus on Demand Removal of the Syndesmotic Screw

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.

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Key information

Conditions

Anke Fracture Ankle Injuries Leg Injuries Syndesmotic Injury Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Academic Medical Center

Amsterdam, North Holland, 1105AZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Removal on demand of the syndesmotic screw

Procedure

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

Procedure

The syndesmotic screw will routinely be removed 8 - 12 weeks following placement of the screw

Primary outcomes

  1. Functional outcome through the Olerud-Moland score

    Time frame: 1 year following initial treatment

Secondary outcomes

  1. Functional outcome through the OAFAS

    Time frame: 1 year following initial treatment

  2. Pain through the Visual Analog scale

    Time frame: 1 year following initial treatment

  3. Range of motion

    Time frame: 1 year following initial treatment

  4. Surgical complications

    Time frame: 1 year following initial treatment

  5. Quality of Life through the EQ-5D-5L

    Time frame: 1 year following initial treatment

  6. Health care consumption through the iMCQ

    Time frame: 1 year following initial treatment

  7. Loss of productivity through the iPCQ

    Time frame: 1 year following initial treatment

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: RODEO

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 12, 2016
Registry last updated
Jul 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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