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Edema measurement in trauma patients with a fracture of the lower extremities in the rehabilitation phase.


- candidate number22793
- NTR NumberNTR5406
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-aug-2015
- Secondary IDs15-N-137b METC Atrium-Orbis-Zuyd
- Public TitleEdema measurement in trauma patients with a fracture of the lower extremities in the rehabilitation phase.
- Scientific TitleEdema measurement at the height of the ankle in trauma patients with a fracture of the lower extremities.
- ACRONYMOedeemfractuur
- hypothesisInvestigate whether we can reliably measure the edema of Investigate whether it is possible to reliably measure the edema of the lower extremities by means of a tape measure on both ankles of the rehabilitants and follow the edema longitudinally through time. An increase in edema at the height of the ankle is a sign of overload and requires adaptation of the rehabilitation program.
- Healt Condition(s) or Problem(s) studiedTrauma , Fracture , Lower extremity, , Edema
- Inclusion criteriaTrauma patients with fractures of the lower extremities, including pelvic injury.
- Exclusion criteriaAmputation patients ( thigh, leg , foot) and bilateral lower extremity injury .
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-okt-2015
- planned closingdate1-okt-2016
- Target number of participants20
- InterventionsIn each patient, the edema at the level of the ankles will be measured with a tape measure.
- Primary outcomeIs there a difference in edema between the ankles in trauma patients with fracture of the lower extremities.
- Secondary outcomeComplications related with increased edema
- TimepointsDuring the day the edema at the level of the ankles will be measured with a tape measure
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMsc Pishtiwan Kalmet
- CONTACT for SCIENTIFIC QUERIESMD PhD M. Poeze
- Sponsor/Initiator Netwerk Acute care Limburg Maastricht , Adelante Centre of Expertise in Rehabilitation and Audiology
- Funding
(Source(s) of Monetary or Material Support)
Netwerk Acute care Limburg Maastricht, Adelante Rehabilitation centre Hoensbroek
- PublicationsI will let u know about the progress of the research. If there will be a publication u will be contacted.
- Brief summaryThere is no available information in the literature about the development of edema in the affected limb in trauma patients with fracture of the lower extremities. There is no knowledge about the edema process over time in patients with a fracture of the lower extremities who are allowed to have permissive weight bearing. Is an increased edema in the affected side a sign of inflammation? Can we demonstrate differences in edema in the fractured side relative to the contralateral side? Is this inflammatory response useful as feedback to be given to patients and therapists to better individualize the weight bearing?
The aim of this study is to investigate whether it is possible to reliably measure the edema of the lower extremities at the height of the ankles by using a tape measure to measure edema of rehabilitants and to follow them longitudinally. The hypothesis is that an increase of edema at the level of the ankle is a sign of overload and requires adaptation of the rehabilitation program. The study population is trauma patients with a fracture of the lower extremities that are clinically admitted in Adelante Rehabilitation Centre.
- Main changes (audit trail)23-dec-2015: Amendement:

Inclusion criteria: Trauma patients with fractures of the lower extremities, including pelvic fractures.

Exclusion crteria: Amputation patients (thigh,leg,foot) and bilateral fracture of the lower extremities.

Interventions: The edema at the height of the ankle will be measured with a tape measure in trauma patients who have had a fracture of the lower extremities.

Timepoints: At the end of the day the edema will be measured. If there is an increase in edema and the patient is having complaints, the rehabilitation program will be adapted.
- RECORD25-aug-2015 - 23-dec-2015


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