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Clinical value of ultrasound in reduction of displaced wrist fractures


- candidate number24333
- NTR NumberNTR5837
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-mei-2016
- Secondary IDs15-T-139 METC Zuyderland Medisch Centrum
- Public TitleClinical value of ultrasound in reduction of displaced wrist fractures
- Scientific TitleClinical value of ultrasound guided reduction of dorsally angulated distal radius fractures
- ACRONYMCURADA / KERADA
- hypothesisUltrasound guided reduction of dorsally angulated distal radius fractures will reduce the amount of attemps necessary to achieve an acceptable result compared to the standard blind procedure
- Healt Condition(s) or Problem(s) studiedDistal radius fracture
- Inclusion criteria1. dorsally angulated distal radius fractures
2. need for reduction
- Exclusion criteria1. < 18 years of age
2. multiple fractures, except simple fractures of processus styloideus of the distal ulna
3. high energetic trauma
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2016
- planned closingdate1-mei-2017
- Target number of participants139
- InterventionsUse of ultrasound during reduction of a distal radius fracture to assess the position of bony parts during reduction (which allows rapid correction) and not only after reduction with conventional X-ray imaging
- Primary outcomeNumber of reduction-attempts before acceptable result is achieved
- Secondary outcome1. Need for surgery
2. total amound of costs
3. patients limitations, difference in DASH score between point 0 and 16 weeks after inclusion
- Timepoints1-2-2016: start inclusion
1-1-2017: stop inclusions and finish dataset
1-4-2017: statistical analysis of results
1-5-2017: writing and rewriting article
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc Rick G.M.A. Thissen
- CONTACT for SCIENTIFIC QUERIESMSc Rick G.M.A. Thissen
- Sponsor/Initiator Zuyderland Medical Center, Heerlen
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications
- Brief summaryThe goal of this study is to research the clinical value of ultrasound guided reduction of a dorsally angulated distal radius fracture. Ultrasound guided reduction of a dorsally angulated distal radius fracture is expected to reduce the number of attempts necessary to achieve an adequate position of the fracture and it is expected to improve the function of the wrist in long term. This study will be conducted in the Zuyderland Medical Centre in Heerlen, the Netherlands. It is a randomised single blinded study. Participants in the interventiongroup will recieve an ultrasound guided approach to reduce the fracture. Participants in the control group will recieve the current 'blind' technique of reducing the fracture.
- Main changes (audit trail)
- RECORD10-mei-2016 - 22-jun-2016


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