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

Primary Purpose

Anke Fracture, Syndesmotic Injury

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Removal on demand of the syndesmotic screw
Routine removal of fhe syndesmotic screw
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anke Fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Academic Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control group

Intervention

Arm Description

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

The syndesmotic screw will only be removed in case of symptomatic implants (e.g. implants causing pain or restricted range of motion)

Outcomes

Primary Outcome Measures

Functional outcome through the Olerud-Moland score

Secondary Outcome Measures

Functional outcome through the OAFAS
Pain through the Visual Analog scale
Range of motion
Surgical complications
Quality of Life through the EQ-5D-5L
Health care consumption through the iMCQ
Loss of productivity through the iPCQ

Full Information

First Posted
September 7, 2016
Last Updated
July 8, 2020
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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1. Study Identification

Unique Protocol Identification Number
NCT02896998
Brief Title
Routine Versus on Demand Removal of the Syndesmotic Screw
Acronym
RODEO
Official Title
Routine Versus on Demand Removal of the Syndesmotic Screw
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 2017 (undefined)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
May 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anke Fracture, Syndesmotic Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
197 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Other
Arm Description
The syndesmotic screw will routinely be removed 8 - 12 weeks following placement of the screw
Arm Title
Intervention
Arm Type
Experimental
Arm Description
The syndesmotic screw will only be removed in case of symptomatic implants (e.g. implants causing pain or restricted range of motion)
Intervention Type
Procedure
Intervention Name(s)
Removal on demand of the syndesmotic screw
Intervention Description
The syndesmotic screw will only be removed in case of a symptomatic implant (e.g. implant causing pain or restricted range of motion)
Intervention Type
Procedure
Intervention Name(s)
Routine removal of fhe syndesmotic screw
Intervention Description
The syndesmotic screw will routinely be removed 8 - 12 weeks following placement of the screw
Primary Outcome Measure Information:
Title
Functional outcome through the Olerud-Moland score
Time Frame
1 year following initial treatment
Secondary Outcome Measure Information:
Title
Functional outcome through the OAFAS
Time Frame
1 year following initial treatment
Title
Pain through the Visual Analog scale
Time Frame
1 year following initial treatment
Title
Range of motion
Time Frame
1 year following initial treatment
Title
Surgical complications
Time Frame
1 year following initial treatment
Title
Quality of Life through the EQ-5D-5L
Time Frame
1 year following initial treatment
Title
Health care consumption through the iMCQ
Time Frame
1 year following initial treatment
Title
Loss of productivity through the iPCQ
Time Frame
1 year following initial treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Academic Medical Center
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1105AZ
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
29386053
Citation
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. Erratum In: BMC Musculoskelet Disord. 2020 Aug 5;21(1):520.
Results Reference
derived

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Routine Versus on Demand Removal of the Syndesmotic Screw

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