Trial document





This trial has been registered retrospectively.
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  DRKS00003332

Trial Description

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Title

Early functional Results after Hemiarthroplasty for Fractured Neck Femur: A Randomized Comparison between a Minimal Invasive (DAA) and a Conventional (Watson-Jones) Approach

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Trial Acronym

MIS-DAA

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URL of the Trial

http://www.biomechatronics.de

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Brief Summary in Lay Language

It was our hypothesis that geriatric patients with a fractured neck of femur, when surgically treated via a direct anterior approach to the hip, would regain their mobility faster. Measurement was performed with the Barthel index. Study participants were patients of a single unit that sustained a femoral neck fracture.

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Brief Summary in Scientific Language

Patients who sustained a fractured neck of femur were randomly assigned into two groups. In the minimal invasive arm, a so called “direct anterior approach” (DAA) was chosen, in the conventional arm Watson-Jones-Approach was used for implantation of a bipolar hemi-arthroplasty.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00003332
  •   2011/12/15
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  •   yes
  •   Approved
  •   Votum 06-156, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

  •   U1111-1126-4556 
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Health Condition or Problem studied

  •   Fractured neck of femur
  •   S72.0 -  Fracture of neck of femur
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Interventions/Observational Groups

  •   MIC DAA, implantation of a bipolar hip prosthesis via a “direct anterior approach” (DAA) access
  •   Watson-Jones-Approach (WJA): Implantation of a bipolar hip arthoplasty via a WJA
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Single blind
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  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
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Primary Outcome

4 item Barthel Index (Measurement of Mobility)
Day 1,5,16,40

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Secondary Outcome

Stand up and Go test, blood loss, complications days 1, 5, 16, 40

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2008/01/01
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

fractured neck of femur< 48 hrs ago

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Exclusion Criteria

Inability for informed consent, other procedure than bibolar hemiarthroplasty, bedridden

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Addresses

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    • UK-SH, Campus Lübeck
    • Mr.  Dr med  Felix   Renken 
    • Ratzeburger Allee 160
    • 23568  Lübeck
    • Germany
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    • Universität zu Lübeck
    • Mr.  PD Dr.  Arndt P.  Schulz 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Study Nurse, UK-SH, Campus Lübeck
    • Ms.  Sylvia  Schlottau 
    • Ratzeburger Allee 160
    • 23568  Lübeck
    • Germany
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Sources of Monetary or Material Support

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    • Universität zu Lübeck
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2010/12/31
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Trial Publications, Results and other Documents

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