Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00018693

Trial Description

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Title

Motor vehicle driving after total knee or hip arthroplasty

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Operating a motor vehicle after a total knee or hip arthroplasty is of great importance, especially for people living in rural areas such as the German countryside. The official statement is that motor vehicle driving should not be resumed earlier than 3 months after total knee or hip arthroplasty. After conducting a thorough literature research, no studies regarding postoperative motor vehichle driving after total knee or hip arthroplasty were identified in the German speaking countries. Likewise, no such refrences were identified in the national German S2k and S3 Therapy Guidelines for Gon/Coxarthtosis. From our clinical experience we could determine that a large propotion of such patients resume motor vehicle driving earlier than 3 months after total hip or knee arthroplasty.

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Brief Summary in Scientific Language

Monocentric observational study. Participants were required to give their written consent in order to take part, after having been given a detailed presentation of the study.Twelve weeks after surgery, the participants would be aksed via a thelephone conversation with a researcher to complete a questionnaire regarding postoperative pain, use of crutches, resuming motor vehicle driving, type of vehicle transmition used, frequency of vehicle usage and purpose. All the data will be anonymously used and interpreted, and it's according to the new European General Data Protection Regulation (EU) 2016/679 current version of the OJ L 119, 04.05.2016; cor. OJ L 127, 23.5.2018.

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Organizational Data

  •   DRKS00018693
  •   2019/09/20
  •   [---]*
  •   yes
  •   Approved
  •   18/19, Ethik-Kommission des Landes Sachsen-Anhalt
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Secondary IDs

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

  •   Motor vehicle driving after total knee or hip arthroplasty
  •   M16.1 -  Other primary coxarthrosis
  •   M17.1 -  Other primary gonarthrosis
  •   Z96.64 -  [generalization Z96.6: Presence of orthopaedic joint implants]
  •   Z96.65 -  [generalization Z96.6: Presence of orthopaedic joint implants]
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Interventions/Observational Groups

  •   The participants were required to give their written consent in order to take part, after having been given a detailed presentation of the study.Twelve weeks after surgery, the participants would be aksed via a thelephone conversation with a researcher to complete a questionnaire regarding postoperative pain, use of crutches, resuming motor vehicle driving, type of vehicle transmition used, frequency of vehicle usage and purpose.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   I
  •   N/A
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Primary Outcome

The primary goal of this study is to identify the discrepancy between the official recommended 12 weeks post-surgery driving ban and the actual driving practices of postoperative patients and to provide a statistical analysis of the time elapsed befor resuming driving after total knee or hip arthroplasty.
After reaching 100 recruited participants this study will be concluded.

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Secondary Outcome

Secondary goal is to have a scientific basis for the second phase of the study - to objectively evaluate motor vehicle driving after total knee or hip arthroplasty

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2019/07/22
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

primary knee or hip total arthroplasty
valid drivers license
pre-surgery driving habits

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Exclusion Criteria

hip arthtoplasty after trauma
posttraumatic arthritis of the hip and knee joint

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Teufelsbad Fachklinik Blankenburg
    • Mr.  Tiberiu Adrian  Lazar 
    • Micahelstein 18
    • 38889  Blankenburg
    • Germany
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    • Teufelsbad Fachklinik Blankenburg
    • Mr.  Tiberiu  Lazar 
    • Michaelstein 18
    • 38889  Blankenburg
    • Germany
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    • Teufelsbad Fachklinik Blankenburg
    • Mr.  Dr. med.  Martin  Edelmann 
    • Michaelstein 18
    • 38889  Blankenburg
    • Germany
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Sources of Monetary or Material Support

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    • Teufelsbad Fachklinik Blankenburg
    • Mr.  Tiberiu-Adrian  Lazar 
    • Michaelstein 18
    • 38889  Blankenburg
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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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.