Trial document





This trial has been registered retrospectively.
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  DRKS00005638

Trial Description

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Title

Treatment of distal radius fractures with K-Wires versus palmar locking plates

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Comparison of two treatmentoption (wire vs. platefixation) in dital radius fracture

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Brief Summary in Scientific Language

prospectiv randomised comparision of less invasive osteosynthesis vs. locking plate fixation of distal radius extension fractures in function and radiological result

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Organizational Data

  •   DRKS00005638
  •   2014/01/13
  •   [---]*
  •   yes
  •   Approved
  •   3410, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

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Health Condition or Problem studied

  •   S52.10 -  [generalization S52.1: Fracture of upper end of radius]
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Interventions/Observational Groups

  •   less invasive stabalization of distal radius fracture
  •   ORIF (Open Reduction Internal Fixation) with angle stabile plate fixation of distal radius fracture
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

function: DASH (Disability of Arm-, Shoulder-, and Hand) - Score: 12 month after surgery

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Secondary Outcome

radiological malaligment in X-ray wrist a.p. and lateral: 12 month after surgery

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2004/01/13
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

extension fracture of the distal radius

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Exclusion Criteria

Former injury or disease of the wrist, old fracture (>72h)
Degenerative disease of the wrist
Metabolic disease
Immunosuppression
Pathological fracture
Pregnancy
Bleeding Disorder
age<18 years

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Addresses

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    • Medizinische Hochschule Hannover
    • Carl Neuberg Strasse 1
    • 30625  Hannover
    • Germany
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    •   [---]*
    •   [---]*
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    • Unfall-, Hand- und Wiederherstellende ChirurgieOrtenau Klinikum Offenburg
    • Mr.  Priv.-Doz. Dr.  Reinhard  Meier 
    • Ebertplatz 12
    • 77654  Offenburg
    • Germany
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    • Unfallchirurgische KlinikMedizinische Hochschule Hannover
    • Mr.  Priv.-Doz.  Reinhard  Meier 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Medartis AG
    • Hochbergerstrasse 60E
    • 4057  Basel
    • Switzerland
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Status

  •   Recruiting complete, follow-up complete
  •   2005/04/29
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.