Trial document




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  DRKS00016519

Trial Description

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Title

Postoperative Rehabilitation and Pain Development after Hip-Arthroplasty - Prospective Analysis and Comparison of 3 different Approaches

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Postoperative pain management options are important for hip replacement patients because joint replacement surgery is considered one of the most painful surgical procedures. The aim of this study is to find out the pain results up to 4 weeks postoperatively and pain influencing factors in the postoperative course after hip arthroplasty. In addition, a comparison of different approaches (anterior, lateral and posterior approach) is to be made in order to ascertain a possible influence of the approach on postoperative rehabilitation.

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Brief Summary in Scientific Language

The aim of this study is to find out the pain results up to 4 weeks postoperatively and pain influencing factors in the postoperative course after hip arthroplasty. In addition, a comparison of different approaches (anterior, lateral and posterior approach) will be carried out in order to determine a possible influence of access on postoperative rehabilitation (pain level, amount of analgesia, time of mobilisation, complications). To the best of our knowledge, there are no publications that compare all common 3 approaches against each other. Prospectively 150 patients are to be included.

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Organizational Data

  •   DRKS00016519
  •   2019/08/15
  •   [---]*
  •   yes
  •   Approved
  •   F-2019-006, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
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Secondary IDs

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

  •   M16 -  Coxarthrosis [arthrosis of hip]
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Interventions/Observational Groups

  •   Patients after primary implantation of a total hip endoprosthesis,
    Questionnaire (modified Harris Hip Score, UCLA Activity Score) preoperative, 1 week postoperative and 4 weeks postoperative with psychological and general variables and satisfaction. In addition, daily assessment of pain level, amount of analgesia, degree of mobilization and complications during inpatient stay
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Characteristics

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

Assessment of the postoperative pain level after implantation of hip arthroplasty using VAS as well as postoperative mobilization compared to three different approaches (anterior, lateral, posterior).

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Secondary Outcome

Assessment of possible complications compared to three different approaches (anterior, lateral, posterior).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2019/08/14
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

primary, elective implantation of hip arthroplasty

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Exclusion Criteria

revisions, infections, fractures

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Addresses

  • start of 1:1-Block address primary-sponsor
    • ARCUS Kliniken
    • Mr.  Dr.  Alexander  Zimmerer 
    • Rastatterstr. 17-19
    • 75179  Pforzheim
    • Germany
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    • ARCUS Kliniken
    • Mr.  Dr.  Alexander  Zimmerer 
    • Rastatterstr. 17-19
    • 75179  Pforzheim
    • Germany
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    • ARCUS Kliniken
    • Mr.  Dr.  Alexander  Zimmerer 
    • Rastatterstr. 17-19
    • 75179  Pforzheim
    • Germany
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Sources of Monetary or Material Support

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    • ARCUS Kliniken
    • Mr.  Dr.  Alexander  Zimmerer 
    • Rastatterstr. 17-19
    • 75179  Pforzheim
    • 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.