search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Operation or Plaster in Wrist Fractures


- candidate number21107
- NTR NumberNTR4915
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-dec-2014
- Secondary IDsNL51544.018.14 
- Public TitleOperation or Plaster in Wrist Fractures
- Scientific TitleInternal Plate Fixation versus Plaster in Complete Articular Distal Radius Fractures
- ACRONYMVIPAR
- hypothesisOpen reduction and internal plate fixation has a better functional outcome compared to closed reduction and plaster immobilisation.
- Healt Condition(s) or Problem(s) studiedWrist fracture, Radius
- Inclusion criteria• Patients from 18 – 65 years
• AO type C displaced distal radius fracture, as classified on lateral, posterior anterior and lateral carporadial radiographs/CT-scan by a radiologist or trauma surgeon
• Fracture displacement is defined by the AO foundation as ‘fragments not perfectly anatomically aligned’. Acceptable closed reduction obtained immediately after admission to the Emergency Department (<12hrs)
- Exclusion criteria• Patients with impaired wrist function prior to injury due to arthrosis/neurological disorders of the upper limb
• Open distal radius fractures
• Multiple trauma patients (Injury Severity Score (ISS) ≥16)
• Other fractures of the affected extremity (except from ulnar styloid process)
• Fracture of other wrist
• Insufficient comprehension of the Dutch language to understand a rehabilitation program and other treatment information as judged by the attending physician
• Patient suffering from disorders of bone metabolism other than osteoporosis (i.e. Paget’s disease, renal osteodystrophy, osteomalacia)
• Patients suffering from connective tissue disease or (joint) hyperflexibility disorders such as Marfan’s, Ehler Danlos or other related disorders
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2015
- planned closingdate1-jan-2019
- Target number of participants90
- InterventionsOpen reduction and internal plate fixation versus plaster immobilisation
- Primary outcomePRWE
- Secondary outcomeDASH, SF36, VAS, ROM, grip strength, radiographic outcomes, cost-effectiveness and cost-utility
- Timepoints1 week, 2/3 weeks, 6 weeks, 3 monhts, 6 months, 12 months
- Trial web sitewww.viparstudie.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. J.C. Goslings
- CONTACT for SCIENTIFIC QUERIESMD PhD N.W.L. Schep
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryThere is no consensus about the best treatment for patients with displaced complete articular distal radius fractures (AO type C fractures). Despite this lack of consensus and the lack of available literature on comparative data to guide treatment for this patient population, operative treatment with plate fixation has gained popularity. The aim of our study is to compare the functional outcome of open reduction and plate fixation with closed reduction and plaster immobilisation in adult patients (18-65 years) with displaced complete articular distal radius fractures.
- Main changes (audit trail)25-nov-2016:

Inclusion NEW:
• Patients from 18 – 75 years
- RECORD3-dec-2014 - 25-nov-2016


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