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Vacoped Protocol Studie


- candidate number18075
- NTR NumberNTR4696
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-jun-2014
- Secondary IDs
- Public TitleVacoped Protocol Studie
- Scientific Title-
- ACRONYM-
- hypothesis1. A safe and effective treatment protocol for the Vacoped is: Application of the Vacoped in the operating theatre/emergency department, with partial load-bearing up to 20 kg allowed from day 2. Full load bearing is allowed from day 10-14, with a total treatment duration of 6 weeks.
2. The Vacoped is comfortabel, easy to use and causes little pain.
3. Usage of the Vacoped leads to quick restoration of functionality without a high rate of complications.
4. The Vacoped achieves functional results which are at least as good as normal plaster cast, and is at least as safe.
- Healt Condition(s) or Problem(s) studiedAnkle fracture, Lower extremity
- Inclusion criteriaTrauma to the foot or inferior lower limb, age 16 years or older, treated in the Atrium Medisch Centrum in Heerlen, where treatment has been with either the Vacoped or plaster cast.
- Exclusion criteriaOpen fractures, medical conditions limiting use of arms/hands
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 16-jun-2014
- planned closingdate1-feb-2015
- Target number of participants128
- InterventionsVacoped walker
- Primary outcomeFunctional results
Complication rates
- Secondary outcomeFunctional results per Vacoped protocol
Complication rates per Vacoped protocol
Patient perception of the Vacoped
- Timepoints2 months post-treatment
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Martin Brakel, van
- CONTACT for SCIENTIFIC QUERIES Martin Brakel, van
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD11-jun-2014 - 17-aug-2014


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