Trial document




This trial has been registered retrospectively.
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  DRKS00016927

Trial Description

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Title

Two-stage Revision shoulder arthroplasty after deep infection of the shoulder: functional outcome, complications ans prognoses

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

The incidence of infections after primary shoulder arthroplasty is between 1 – 5% in literature, with even higher rates after reverse shoulder arthroplasty. The shoulder infection can be treated by surgical debridement with one stage or two stage exchange of the prosthesis or resection arthroplasty. The best outcomes for eradication of the infection has been reported by one or two stage revision and the resection arthroplasty. In this study we follow patients with deep infections of the shoulder after arthroplasties, rotator cuff surgery or fracture fixation that were treated with two stage revision arthroplasty. The patients have to be over 18 years old. One year after arthroplasty we check the functional outcome, complications like reinfection or dislocation and the general satisfaction of the patients.

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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

  •   DRKS00016927
  •   2019/03/19
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  •   yes
  •   Approved
  •   2018-13493, Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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Secondary IDs

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Health Condition or Problem studied

  •   T84.5 -  Infection and inflammatory reaction due to internal joint prosthesis
  •   T84.6 -  Infection and inflammatory reaction due to internal fixation device [any site]
  •   M00.91 -  [generalization M00.9: Pyogenic arthritis, unspecified]
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Interventions/Observational Groups

  •   Patients, aged 18 or older, which had a deep infection of the shoulder and a two stage Revision shoulder arthroplasty

    Follow-up one year after arthroplasty: clinical examination, anaysis of questionnaires and the patients health record
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Characteristics

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

- DASH (Disabilities of the arm, the shoulder and the Hand) score one year after arthroplasty
- Constant Shoulder Score one year after arthroplasty

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Secondary Outcome

- Satisfaction of the patients one year after arthroplasty, acquisition by standardised questionnaire
- Reinfection- and dislocationrate one year after arthroplasty, acquisition by anamnesis and the patients health record

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2019/01/01
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- Patients aged older than 18
- Deep infection of the shoulder after surgery
- two-stage revision shoulderarthroplasty

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Exclusion Criteria

Patients younger than 18 years.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • BG Klinik Ludwigshafen
    • Ms.  Sandra  Hornung 
    • Ludwig-Guttmann-Str. 13
    • 67071  Ludwigshafen
    • Germany
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    • BG Klinik Ludwigshafen
    • Ms.  Sandra  Hornung 
    • Ludwig-Guttmann-Str. 13
    • 67071  Ludwigshafen
    • Germany
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    • BG Klinik Ludwigshafen
    • Ms.  Sandra  Hornung 
    • Ludwig-Guttmann-Str. 13
    • 67071  Ludwigshafen
    • Germany
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Sources of Monetary or Material Support

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    • BG Klinik Ludwigshafen
    • Ms.  Sandra  Hornung 
    • Ludwig-Guttmann-Str. 13
    • 67071  Ludwigshafen
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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