Trial document





This trial has been registered retrospectively.
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  DRKS00000094

Trial Description

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Title

"The posttraumatic Hiparthrosis after Acetabular Fracture"
Retrospective Analysis of Hip data base AG I-III

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The long term results after treatment in acetabular fractures are despite of the progress in operative treatment still dissatisfying. Based on a large nationwide multicenter clinical trial it will be able to forecast a realistic outcome after acetabular fractures.
With the help of the outstanding number of patients collected in this study, it will be possible to find out new variables for the genesis of hip athrosis after acetabular fractures and new findings to avoid posttraumatic hiparthrosis.

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Brief Summary in Scientific Language

Acetabular fractures are serious injuries that happened generally to young people. Despite of the progress in operative treatment of acetabular fractures, in 20% - 50 % cases the result is an early osteoarthritis. The surgical intervention is very sophisticated and sometimes associated with a high risk of intraoperative complications.
The final achievement of the therapy and prognosis of the fracture is only in the course of time possible to evaluate. Because of this reason, our clinical trial is applied with simple defined long term parameters: 1- free of symptoms in the hip, 2- painful, but original hip joint, 3- total hip replacement or hip - arthrodesis. We will contact the patients by mail or by telephone to evaluate the parameters specified above. Because we possess the detailed list of the acute-phase and perioperative parameters, we hoped to identify more detailed prognosis factors of the acetabular osteoarthrosis with help of different statistical analysis (e.g. multivariate analysis).

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Organizational Data

  •   DRKS00000094
  •   2009/04/22
  •   [---]*
  •   yes
  •   Approved
  •   21/09, Ethik-Kommission bei der Ärztekammer des Saarlandes
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Secondary IDs

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

  •   M19.15 -  [generalization M19.1: Post-traumatic arthrosis of other joints]
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Interventions/Observational Groups

  • [---]*
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Characteristics

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

Hip replacement or Hip arthrodesis.

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Secondary Outcome

Health-related quality of life proof with SF12 and EQ 5D
Clinical osteoarthritis (Merle d'Aubigne score)
Radiological osteoarthritis (Kellgren-score)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2009/02/05
  •   1102
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Age over 18y
Acetabulum fracture without severe accompanying injuries (ISS<22)
No unstable pelvic fractures type C
No spinal cord injuries with neurological deficit
Follow up two years after injury

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Exclusion Criteria

Unstable pelvic fractures type C
ISS>22 points
Age <18y
Neurological deficit because of other reasons than acetabulum fractures
Polytraumatized Patient
Existing coxarthrosis before injury
Femoral head necrosis
Systemic medication with corticosteroide
Chronic systemic inflammation disease

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum des Saarlandes Klinik für Unfall-, Hand- und Wiederherstellungschirurgie
    • Mr.  Prof. Dr. med.  Tim  Pohlemann 
    • Kirrberger Strasse 1
    • 66421  Homburg
    • Germany
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    • Universitätsklinikum des Saarlandes Klinik für Unfall-, Hand- und Wiederherstellungschirurgie
    • Mr.  PD   Jörg  Holstein 
    • Kirrberger Straße
    • 66421  Homburg/Saar
    • Germany
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    • Universitätsklinikum des Saarlandes Klinik für Unfall-, Hand- und Wiederherstellungschirurgie
    • Ms.  Sabine  Drum 
    • Kirrberger Straße 1
    • 66421  Homburg/Saar
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Arthrose-Hilfe
    • Mr.  Dr. med.  Helmut  Huberti 
    • Neue-Welt-Str. 4-6
    • 66740  Saarlouis
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
  •   2011/01/31
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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.