Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00000606

Trial Description

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Title

Instrumented Knee Joint Prostheses: Load measurements in patients using instrumented
endoprosthesis

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of this study is to determine the loading of total knee replacements in patients during various activities.

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Brief Summary in Scientific Language

The aim of this study is to determine the loading of total knee replacements during various activities.
This information is essential for preclinical testing of implants and the development of new implants. In vivo load measurements in combination with gait analysis allow the validation of muskuloskeletal models.

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Organizational Data

  •   DRKS00000606
  •   2010/11/05
  •   [---]*
  •   yes
  •   Approved
  •   EA4/069/06, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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

  •   M17 -  Gonarthrosis [arthrosis of knee]
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Interventions/Observational Groups

  •   The patients participating in this study will receive an instrumented knee joint
    prostheses due to osteoarthritis.
    At an eraly post-operative time in-vivo load measurements will be performed during physiotherapy. Later on varoius activies will be inverstigated such as walking, stair climbing, two legged stance and nordic walking for example.
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Characteristics

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

During the first post-operative time measurements will be performed once a week.
During the first 6 months post-operative and after the hospital stay, measurments will be performed once a month and later on approximately every six months.

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Secondary Outcome

In the course of the study a gait analysis will be performed with the patients.
For this purpose, the patients receive reflective markers taped to the skin. The movement of the markers is recorded by an an infrared camera system and allows to analyse the individual kinematic of each subject.
Force plates in the floor allow the
simultaneous recording of ground reaction forces. This synchronous motion and load measurment allows the validation and improvement of musculoskeletal models.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2007/03/13
  •   10
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Only physically active patients with osteoarthritis that need a conventional total knee joint replacement. Bodyweight below 100kg.

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Exclusion Criteria

Excluded are all patients with active implants (e.g. cardiac pacemakers).

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Addresses

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    • Zimmer GmbH
    • Sulzerallee 8
    • 8404  Winterthur
    • Switzerland
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Julius Wolff Institut Charité - Universitätsmedizing Berlin
    • ***  *** 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Julius Wolff Institut Charité - Universitätsmedizin Berlin
    • ***  *** 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Zimmer GmbH
    • Sulzer Allee 8
    • 8404  Winterthur
    • Switzerland
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Deutsch Arthrose-Hilfe e.V.
    • 60040  Frankfurt/Main
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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* This entry means the parameter is not applicable or has not been set.
*** This entry means that data is not displayed due to insufficient data privacy clearing.