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ROutine versus on DEmand removal Of the syndesmotic stabilisation screw; a randomized controlled trial (RODEO-trial)

ROutine versus on DEmand removal Of the syndesmotic stabilisation screw; a randomized controlled trial (RODEO-trial)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20095
Enrollment
196
Registered
2016-07-15
Start date
2016-11-01
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

Ankle/Enkel Fracture/Fractuur Syndesmotic screw/Syndesmose schroef Implant removal/ Verwijderen osteosynthesemateriaal Routine removal/ Routinematig verwijderen schroef Removal on demand/ op indicatie verwijderen schroef Functional outcome/ functioneel herstel Cost-effectiveness/ kosteneffectiviteit

Interventions

We will investigate a removal on demand strategy regarding the syndesmotic screw. This means that patients, in whom a syndesmotic screw has been placed, will not be scheduled for screw removal unless

Sponsors

Academic Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Over 17 years of age • A syndesmotic screw for an instable ankle fracture • 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

Exclusion criteria: • Patients treated with another device than a syndesmotic screw • 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
OMAS

Secondary

MeasureTime frame
• Functional outcome through the American Orthopedic Foot and Ankle Score (AOFAS) • Pain though the Visual analog scale (VAS-score) • Range-of-motion • Surgical complications (such as wound infections) • Recurrent syndesmotic diastasis • Quality of life though the EQ-5D-5L • Health care consumption through the iMCQ • Loss of productivity through the iPCQ

Contacts

Public ContactTim Schepers

AMC

t.schepers@amsterdamumc.nl020 - 566 0260

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)