Trial document




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  DRKS00014572

Trial Description

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Title

Clinical and serum metall minimum 1 year follow-up after hinged total knee revision arthroplasty

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Trial Acronym

Genu X CoCr Study

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URL of the Trial

http:///

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Brief Summary in Lay Language

A follow-up after a revision knee replacement minimum 1 year after surgery is planed. Patient satisfaction as well as serum levels of chrome and cobalt are to be conducted.

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Brief Summary in Scientific Language

Clinical Follow-up with range-of-motion and quality of life (Knee Society Score).
Follow-up of chrome (normal value < 0.5 µg/l) und cobalt (normal value 0.5 – 3.9 µg/l) serum levels without a control group.

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Organizational Data

  •   DRKS00014572
  •   2018/04/06
  •   [---]*
  •   yes
  •   Approved
  •   187/17, Ethik-Kommission des Fachbereichs Medizin der Philipps-Universität Marburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Z96.65 -  [generalization Z96.6: Presence of orthopaedic joint implants]
  •   T84.0 -  Mechanical complication of internal joint prosthesis
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Interventions/Observational Groups

  •   Patients that received a Genu X MK revision total knee arthroplasty at least 12 months prior to beginning of the study. Functional outcome will be assessed using the Knee Society Score, a potential radiograph is going to be performed and a measurement of Chrome (III) and Cobalt in serum will be performed.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Clinical Follow-up with range-of-motion and quality of life (Knee Society Score).
Follow-up of chrome (normal value < 0.5 µg/l) und cobalt (normal value 0.5 – 3.9 µg/l) serum levels without a control group.

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Secondary Outcome

/

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/04/05
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   40   Years
  •   95   Years
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Additional Inclusion Criteria

Patients that received a revision knee Arthoplasty using Genu X MK system between 01/2014 and 03/2017

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Exclusion Criteria

•Patients not willing to participate.

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Addresses

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    • Uniklinik Marburg, Zentrum für Orthopädie und Unfallchirurgie
    • Mr.  Dr. med.  Antonio  Klasan 
    • Baldingerstr.
    • 35043  Marburg
    • Germany
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    • Uniklinik Marburg, Zentrum für Orthopädie und Unfallchirurgie
    • Mr.  Dr. med.  Antonio  Klasan 
    • Baldingerstr.
    • 35043  Marburg
    • Germany
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    • Uniklinik Marburg, Zentrum für Orthopädie und Unfallchirurgie
    • Mr.  Dr. med.  Antonio  Klasan 
    • Baldingerstr.
    • 35043  Marburg
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinik Marburg, Zentrum für Orthopädie und Unfallchirurgie
    • Mr.  Dr. med.  Antonio  Klasan 
    • Baldingerstr.
    • 35043  Marburg
    • Germany
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    • Implantcast GmbH
    • Mr.  Jens  Saß 
    • Lüneburger Schanze 26
    • 21614  Buxtehude
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/05/15
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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.