Trial document





This trial has been registered retrospectively.
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  DRKS00000430

Trial Description

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Title

Navigation of TKA:
Rotation of components and clinical results in a prospectively randomized study

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Trial Acronym

Navigation TKA

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The value if navigation for knee arthroplasty is to be evaluated.

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Brief Summary in Scientific Language

Abstract:
Background:
Navigation was introduced into Total Knee Arthroplasty (TKA) to improve accuracy of component position, function and survival of implants. This study was designed to assess the outcome of navigated TKA in comparison with conventional implantation with the focus on rotational component position and clinical mid-term results.
Methods:
In a prospectively randomized single-blinded approach, 90 patients with primary gonarthrosis were assigned to three different groups. 30 patients each were assigned to NexGen LPS without and with navigation (groups 1 and 2), and 30 patients to navigation with the Stryker Scorpio PS (group 3). Clinical outcome was assessed by a blinded observer applying the Knee Society Score (KSS) and a visual analogue scale. CT scans and radiographs were conducted prior to, and 12 weeks after index surgery.
Results:
79 patients were available for clinical evaluation at 3 ± 0.4 years follow-up. Four implants had to be revised for early loosening or infection (4.4%). Four patients had died and three patients were not able to follow the invitation for clinical assessment. Functional results in the KSS were significantly lower after navigated TKA. Operation time and incisions with navigation were significantly longer. Significantly less radiological outliers with navigation were found for coronal alignment of the femur, only.
Conclusion:
In this series, no beneficial effect for navigation in TKA could be shown assessing clinical data, as functional results in the presented series seemed to be lower after navigated TKA. The clinical mid- to long-term value of navigation remains to be evaluated in larger patient series or meta-analyses at longer follow-up.

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Organizational Data

  •   DRKS00000430
  •   2010/11/26
  •   [---]*
  •   yes
  •   Approved
  •   69/01, Ethik-Kommission des Fachbereichs Medizin der Philipps-Universität Marburg
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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

  •   TKA NexGen non-navigated
  •   TKA NexGen navigated
  •   TKA Scorpio navigated
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Single blind
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  •   Active control
  •   Prognosis
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

Analysis of Rotation of components in CT 3 Months postOP

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Secondary Outcome

Survival of implants at 10 years

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2001/08/06
  •   90
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Indication for TKA

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Exclusion Criteria

Unwilling or unable to give informed consent.

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Addresses

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    • Klinik für Orthopädie und Rheumatologie
    • Baldingerstrasse
    • 35043  Marburg
    • Germany
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    • Klinik für Orthopädie und Rheumatologie
    • Mr.  Dr.  Thomas  Heyse 
    • Baldingerstrasse
    • 35043  Marburg
    • Germany
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    • Klinik für Orthopädie und Rheumatologie
    • Mr.  Dr.  Thomas  Heyse 
    • Baldingerstrasse
    • 35043  Marburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Orthopädie und Rheumatologie
    • Mr.  Dr.  Jan  Schmitt 
    • Baldingerstrasse
    • 35043  Marburg
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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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.