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Routine Versus on Demand Removal of the Syndesmotic Screw

Routine Versus on Demand Removal of the Syndesmotic Screw

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02896998
Acronym
RODEO
Enrollment
197
Registered
2016-09-12
Start date
2017-01-31
Completion date
2020-05-01
Last updated
2020-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anke Fracture, Syndesmotic Injury

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.

Interventions

PROCEDURERemoval 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)

PROCEDURERoutine removal of fhe syndesmotic screw

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Functional outcome through the Olerud-Moland score1 year following initial treatment

Secondary

MeasureTime frame
Pain through the Visual Analog scale1 year following initial treatment
Range of motion1 year following initial treatment
Surgical complications1 year following initial treatment
Functional outcome through the OAFAS1 year following initial treatment
Health care consumption through the iMCQ1 year following initial treatment
Loss of productivity through the iPCQ1 year following initial treatment
Quality of Life through the EQ-5D-5L1 year following initial treatment

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026