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

July 8, 2020 updated by: J.C. Goslings, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

197

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1105AZ
        • Academic Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group
The syndesmotic screw will routinely be removed 8 - 12 weeks following placement of the screw
Procedure: Routine removal of fhe syndesmotic screw
The syndesmotic screw will routinely be removed 8 - 12 weeks following placement of the screw
Experimental: Intervention
The syndesmotic screw will only be removed in case of symptomatic implants (e.g. implants causing pain or restricted range of motion)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Functional outcome through the Olerud-Moland score
Time Frame: 1 year following initial treatment
1 year following initial treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Functional outcome through the OAFAS
Time Frame: 1 year following initial treatment
1 year following initial treatment
Pain through the Visual Analog scale
Time Frame: 1 year following initial treatment
1 year following initial treatment
Range of motion
Time Frame: 1 year following initial treatment
1 year following initial treatment
Surgical complications
Time Frame: 1 year following initial treatment
1 year following initial treatment
Quality of Life through the EQ-5D-5L
Time Frame: 1 year following initial treatment
1 year following initial treatment
Health care consumption through the iMCQ
Time Frame: 1 year following initial treatment
1 year following initial treatment
Loss of productivity through the iPCQ
Time Frame: 1 year following initial treatment
1 year following initial treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Actual)

May 1, 2020

Study Completion (Actual)

May 1, 2020

Study Registration Dates

First Submitted

September 7, 2016

First Submitted That Met QC Criteria

September 7, 2016

First Posted (Estimate)

September 12, 2016

Study Record Updates

Last Update Posted (Actual)

July 10, 2020

Last Update Submitted That Met QC Criteria

July 8, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METC2016_197

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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