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


- candidate number24651
- NTR NumberNTR5965
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-jul-2016
- Secondary IDsNL58539.018.16 
- Public TitleROutine versus on DEmand removal Of the syndesmotic stabilisation screw; a randomized controlled trial (RODEO-trial)
- Scientific TitleROutine versus on DEmand removal Of the syndesmotic stabilisation screw; a randomized controlled trial (RODEO-trial)
- ACRONYMRODEO-trial
- hypothesisThe outcome in patients with removal on demand is not inferior to the outcome in patients with routine removal. By omitting routine removal a reduction in costs will be achieved
- Healt Condition(s) or Problem(s) studiedAnkle fracture
- 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 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
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2016
- planned closingdate1-nov-2019
- Target number of participants193
- InterventionsWe 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 the screw becomes symptomatic. Examples of symptomatic hardware are restricted range-of-motion and prominent screws.
- Primary outcomeOMAS
- Secondary outcome 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
- Timepoints3, 6 and 12 months postoperatively
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Siem Dingemans
- CONTACT for SCIENTIFIC QUERIES Siem Dingemans
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD15-jul-2016 - 30-aug-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl