Trial document





This trial has been registered retrospectively.
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  DRKS00016947

Trial Description

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Title

Clinical outcome after medial open wedge high tibial osteotomy: Comparison of two angular stable locking plates - TomoFixTM versus LOQTEQ® HTO plate

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Comparison between two angular stable locking plates with a correction of the axis of the leg with medial Arthritis on the knee. Participants are between 18 and 50 years old. Are the Loqteq-plates better or equal than the standard plate?

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Brief Summary in Scientific Language

Comparison of two angular stable locking plates with high tibia osteotomy (open wedge) with medial Arthritis on the knee.

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Organizational Data

  •   DRKS00016947
  •   2019/09/02
  •   [---]*
  •   yes
  •   Approved
  •   EA4/055/15, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  •   U1111-1229-8260 
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Health Condition or Problem studied

  •   M17.1 -  Other primary gonarthrosis
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Interventions/Observational Groups

  •   AAP Loqteq-plate®.

    KOOS before surgery and after 12 and 24 month post.
  •   Synthes Tomofix-plate™
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

2 years after surgery, KOOS

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Secondary Outcome

KOOS subscores, Tenger Score, implant failure

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2015/06/01
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   50   Years
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Additional Inclusion Criteria

valg. HTO in open wedge technique with Tomofix ™ - or Loqteq® -plate, Age between 18-50 years old

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Exclusion Criteria

Age under 18 and over 50 years old, no german language skills, supervised person.

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Addresses

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    • MLK Berlin
    • Mr.  Prof.  Wolf  Petersen 
    • Casper-Theyß-Str. 27-31
    • 14193  Berlin
    • Germany
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    • MLK Berlin
    • Mr.  Prof.  Wolf  Petersen 
    • Casper-Theyß-Str. 27-31
    • 14193  Berlin
    • Germany
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    • MLK Berlin / UKB
    • Mr.  Hi-Un  Park 
    • Casper-Theyß-Str. 27-31
    • 14193  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • AAP Implantate AG
    • Lorenzweg 5
    • 12099  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/08/26
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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.