Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00009716

Trial Description

start of 1:1-Block title

Title

Clinical, radiological and survivorship-results 10 years after total knee arthroplasty - a comparison between navigated and conventional technique.

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://-

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

[---]*

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Analysis of clinical and radiological results including implant survivorship 10 years after navigated and conventional total knee arthroplasty

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00009716
  •   2015/12/07
  •   [---]*
  •   yes
  •   Approved
  •   12-101-0147, Ethikkommission an der Universität Regensburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   M17.1 -  Other primary gonarthrosis
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   navigated total knee arthroplasty
  •   conventional total knee arthroplasty
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   No
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

clinical and radiological Long-term results ten years after primary Intervention according to WOMAC score and Knee Society Score (including radiological score)

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

surgical revision

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2013/01/15
  •   350
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   85   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Primary total knee arthroplasty

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

severe varus or valgus deformity more than 15°

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Orthopädische Klinik für die Universität Regensburg im Asklepios Klinikum Bad Abbach
    • Mr.  Prof.  Joachim  Grifka 
    • Kaiser-Karl V. Allee 3
    • 93077  Bad Abbach
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Orthopädische Klinik für die Universität Regensburg im Asklepios Klinikum Bad Abbach
    • Mr.  Dr. med.  Clemens  Baier 
    • Kaiser-Karl V. Allee 3
    • 93077  Bad Abbach
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Regensburg
    • Mr.  Dr. med.  Clemens  Baier 
    • Franz-Josef-Strauss-Allee 11
    • 93053  Regensburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Orthopädische Klinik für die Universität Regensburg im Asklepios Klinikum Bad Abbach
    • Mr.  Dr. med.  Clemens  Baier 
    • Kaiser-Karl V. Allee 3
    • 93077  Bad Abbach
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2015/12/01
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.