Trial document




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  DRKS00007586

Trial Description

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Title

prospective, open label, single arm, monocentric clinical study intended to observe efficacy and safety of the AEON-shaft (artificial hip joint), Fa. Brehm, in patients with osteoarthritis of the hip or a fracture of the femoral neck.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Clinical and radiological examination of patients receveid an artifical hip joint, Fa. Peter Brehm, AEON-shaft.
The follow-up starts one year postoperatively up to five years postoperatively. The first arthroplasty was perfomed february 2014.

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Brief Summary in Scientific Language

Inpatients in the Department of Traumatology, Univerisity Hospital Erlangen, who received a total hip arthroplasty due to the presence of osteoarthritis of the hip or a fracture of the femoral neck are examined up to five years after the surgery at defined points of time. Criteria are Harris-Hip-Score and Oxford-Hip-Score. Additionally an x-ray completes the follow up survey.

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Organizational Data

  •   DRKS00007586
  •   2015/01/30
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  •   yes
  •   Approved
  •   279_13 B, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
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Secondary IDs

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Health Condition or Problem studied

  •   S72.0 -  Fracture of neck of femur
  •   M16 -  Coxarthrosis [arthrosis of hip]
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Interventions/Observational Groups

  •   Patients with a total hip arthorplasty concerning the AEON-shaft, Fa. Peter Brehm GmbH, get a follow up survey 1, 2 and 5 years postoperatively. We perform a clinical examination and a radiological diagnostic.
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Characteristics

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

Follow-up-results one year postoperatively (02/2015).
Oxford-Hip-Score (subjective content) , Harris-Hip-Score (function of the arthroplasty) and an additional radiological diagnostic: x-ray of the Hip in two planes.

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Secondary Outcome

Follow-up-results 2 and 5 years postoperatively (02/2020).
Oxford-Hip-Score (subjective content), Harris-Hip-Score (function of the arthroplasty) and an additional radiological diagnostic: x-ray of the Hip in two planes.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2015/02/01
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

fracture of the femoral neck, osteoarthritis of the hip

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Exclusion Criteria

no exclusion criteria

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Leiter der Unfallchirurgischen Abteilung der Universitätsklinik Erlangen
    • Mr.  Prof.  Friedrich Frank  Hennig 
    • Krankenhausstraße 12
    • 91054  Erlangen
    • Germany
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    • Universitätsklink Erlangen Abteilung für Unfallchirurgie/Orthopädie
    • Ms.  Dr.  Eva  Meier 
    • Krankenhausstr. 12
    • 91054  Erlangen
    • Germany
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    • Universitätsklink Erlangen Abteilung für Unfallchirurgie/Orthopädie
    • Ms.  Dr.  Eva  Meier 
    • Krankenhausstr. 12
    • 91054  Erlangen
    • Germany
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Sources of Monetary or Material Support

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    • Leiter der Unfallchirurgischen Abteilung der Universitätsklinik Erlangen
    • Mr.  Prof.  Friedrich Frank  Hennig 
    • Krankenhausstraße 12
    • 91054  Erlangen
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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