Trial document





This trial has been registered retrospectively.
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  DRKS00006960

Trial Description

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Title

Different kinematics of knees with varus and valgus deformity before and after total knee arthroplasty

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Trial Acronym

Tibio-femoral knee kinematics

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Background: Few data exist of kinematics of knees with varus and valgus deformity combined with osteoarthritis. The purpose of this study was to reveal different (1) tibiofemoral kinematics, (2) medial and lateral gaps and (3) condylar lift-off of osteoarthritic knees with either varus or valgus deformity before and after total knee arthroplasty.
40 patients designated for total knee arthroplasty (TKA) with either varus or valgus deformity are included.
The procedure (TKA) itself is not part of the study.
During the navigated procedure the knee joint is moved from full extension to 120° of flexion for three times. By means of the navigation system tibiofemoral kinematics are displayed and recorded. This measurement lengthens operation time approximately for ten seconds (avarage total surgical time is 1 hour). The recoreded data is later analysed to determine possible differences of knee kinematics between varus and valgus deformities.

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Brief Summary in Scientific Language

Few data exist of kinematics of knees with varus and valgus deformity combined with osteoarthritis. The purpose of this study was to reveal different (1) tibiofemoral kinematics, (2) medial and lateral gaps and (3) condylar lift-off of osteoarthritic knees with either varus or valgus deformity before and after total knee arthroplasty (TKA).


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Organizational Data

  •   DRKS00006960
  •   2014/11/03
  •   [---]*
  •   yes
  •   Approved
  •   10-101-0240, Ethikkommission an der Universität Regensburg
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Secondary IDs

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

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

  •   40 patients designated for total knee arthroplasty (TKA) with either varus or valgus deformity are included.
    The procedure (TKA) itself is not part of the study.
    During the navigated procedure the knee joint is moved from full extension to 120° of flexion for three times. By means of the navigation system tibiofemoral kinematics are displayed and recorded. This measurement lengthens operation time approximately for ten seconds (avarage total surgical time is 1 hour). The recoreded data is later analysed to determine possible differences of knee kinematics between varus and valgus deformities.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Finished recording of tibiofemoral kinematics after imlantation of the prosthesis during the operation.
Collected data is later analysed to display possible differences in knee kinematics of varus and valgus deformities.

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Secondary Outcome

tibio-femoral kinematics which is recorded during the operation.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2011/01/10
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

primary osteoarthritis of the knee

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Exclusion Criteria

Patients older than 85 years of age, patients with secondary osteoarthritis of the knee, severe varus or valgus deformity (> 15 degrees) requiring a hinged implant or patients not willing to participate were excluded from the study.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Orthopädische Klinik für die Universität Regensburg
    • Mr.  Dr. med.  Clemens  Baier 
    • Kaiser-Karl V.-Allee 3
    • 93077  Bad Abbach
    • Germany
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    • 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
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    • 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
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Sources of Monetary or Material Support

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    • Universitätsklinikum Regensburg
    • Franz-Josef-Strauss-Allee 11
    • 93053  Regensburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/08/04
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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.