Trial document





This trial has been registered retrospectively.
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  DRKS00000393

Trial Description

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Title

Changes in locomotion behavior after total knee arthroplasty

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Trial Acronym

[---]*

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URL of the Trial

http://nicht vorhanden

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Brief Summary in Lay Language

Total knee arthroplasty (TKA) aims for pain relief and an improvement of quality of life in patients suffering from knee osteoarthritis. However, no data is available whether patients' locomotor activities in daily life after surgery exceed the values before surgery even though patients are encouraged to become physical active after surgery in the context of rehabilitation and reintegration in the community. In this study, 40 patients scheduled for primary TKA are to be monitored regarding their locomotion behavior before surgery, after rehabilitation as well as 6 and 12 months after surgery using objective measurement devices. The SF-36 questionnaire is used to evaluate quality of life. Thus, the improvement in quality of life and the changes in physical activity patterns can be revealed.

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Brief Summary in Scientific Language

The incidence of knee osteoarthritis (OA) is ~30% in 60 years old subjects. Knee OA is known to affect overall quality of life and therefore the treatment of the disease focuses on pain relief, improving joint function as well as delaying the progression of degenerative changes. After total knee arthroplasty (TKA), patients expect improvement regarding their quality of life, especially in terms of pain relief and improved mobility in daily life. Furthermore, patients are encouraged by the surgeons to become physically active after TKA.
It has been shown that resuming low-intensity physical activity in daily life is not sufficient for strengthening the affected muscles (e. g. quadriceps). Additionally, even one year after TKA, patients show significant differences to healthy peers, for example in gait velocity and stair walking. To date, no studies evaluated the development of physical activity after TKA compared to the preoperative situation using valid and objective methods. In fact, most of the published studies used questionnaires for the assessment of physical activity, which are known to be potentially biased for example by cognitive limitations. Furthermore, data obtained by lab-based investigations such as gait analysis cannot be transferred to everyday life situations.
Therefore, it can be summarized that
- no studies compared physical activity of TKA patients before and after surgery using objective methods
- most findings are based on questionnaires
- the transferability from lab-based studies to everyday situations is limited

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Organizational Data

  •   DRKS00000393
  •   2010/04/22
  •   [---]*
  •   yes
  •   Approved
  •   3IRosen1, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

  •   U1111-1114-7974 
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Health Condition or Problem studied

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

  •   1. Step-Activity-Monitoring
    The number of gait cycles per minute was recorded for 7 days using the SAM (OrthoCareInnovations, USA).

    2. ADL-Monitoring
    The amount of locomotion, standing, sitting and lying was measured for one day using the DynaPort ADL-monitor (McRoberts B. V., The Netherlands).

    3. Evaluation of quality of life and clinical outcome
    Quality of lfe was evaluated using the SF-36. The questionnaire includes 36 questions which have to be marked by the patient. The analysis of the total score as well as subscores (such as physical functioning) is possible.
    Clinical outcome was evaluated using the American Knee Society Score, which is applied by the surgeon. The analysis of the total score as well as subscores ("knee" and "function") is possible.
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Supportive care
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

Parameter: Number of daily gait cycles
Point of time: before surgery, 2, 6 and 12 months after surgery
Device: Step-Activity-Monitor

Parameter: Activities of daily living (ADL)
Point of time: before surgery, 2, 6 and 12 months after surgery
Device: DynaPort ADL-Monitor

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Secondary Outcome

Parameter: Quality of life
Point of time: Before surgery and 2, 6 and 12 months after surgery
Instrument: SF-36

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2004/10/05
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Primary total knee arthroplasty due to arthrosis

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Exclusion Criteria

- Implant revision
- TKA at contralateral side
- Total hip arthroplasty (THA)
- TKA on contralateral side/THA scheduled within two years
- any scheduled surgeries at the lower extremities within two years

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Addresses

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    • Klinikum Ingolstadt Orthopädische Klinik
    • Axel  Hillmann 
    • Krumenauerstraße 25
    • 85049  Ingolstadt
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    • Universitätsklinikum Münster Funktionsbereich Bewegungsanalytik
    • Mr.  Prof. Dr.  Dieter  Rosenbaum 
    • Domagkstraße 3
    • 48149  Münster
    • Germany
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    • Klinikum Ingolstadt Orthopädische Klinik
    • Mr.  Prof. Dr.  Axel  Hillmann 
    • Krumenauerstraße 25
    • 85049  Ingolstadt
    • Germany
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Sources of Monetary or Material Support

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    • Zimmer GmbH Winterthur Switzerland
    • Ms.  Friederike  Augustin 
    • Sulzerallee 8
    • 8404  Winterthur
    • Switzerland
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Status

  •   Recruiting complete, follow-up complete
  •   2010/03/15
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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.