NCT02896998

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

July 10, 2020

Status Verified

July 1, 2020

Enrollment Period

3.3 years

First QC Date

September 7, 2016

Last Update Submit

July 8, 2020

Conditions

Anke FractureSyndesmotic Injury

Outcome Measures

Primary Outcomes (1)

  • Functional outcome through the Olerud-Moland score

    1 year following initial treatment

Secondary Outcomes (7)

  • Functional outcome through the OAFAS

    1 year following initial treatment

  • Pain through the Visual Analog scale

    1 year following initial treatment

  • Range of motion

    1 year following initial treatment

  • Surgical complications

    1 year following initial treatment

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

    1 year following initial treatment

  • +2 more secondary outcomes

Study Arms (2)

Control group

OTHER

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

Procedure: Routine removal of fhe syndesmotic screw

Intervention

EXPERIMENTAL

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

Interventions

Removal on demand of the syndesmotic screwPROCEDURE

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

Intervention
Routine removal of fhe syndesmotic screwPROCEDURE

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

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Medical Center

Amsterdam, North Holland, 1105AZ, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 29386053DERIVED

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 7, 2016

First Posted

September 12, 2016

Study Start

January 1, 2017

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

July 10, 2020

Record last verified: 2020-07

Locations

NL(1)