Trial document




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  DRKS00011679

Trial Description

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Title

The use of Bioactive Glass S53P4 as bone graft substitute in the treatment of chronic osteomyelitis and infected non-unions
- a retrospective study of 50 patients.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The aim of our study is to analyse the outcome of patients with COM and/ or infected non-unions, who received a filling of their bone defect with BAG-S53P4 at our institution.
Primary endpoint is the succesful control of infection during the follow-up period. Secondary endpoints are the absence of BAG-S53P4-related complications, the time period to full weight bearing as well as the time period to radiologic detectable incorporation of BAG.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00011679
  •   2017/05/24
  •   [---]*
  •   yes
  •   Approved
  •   30/2017, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

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Health Condition or Problem studied

  •   M86 -  Osteomyelitis
  •   M84.1 -  Nonunion of fracture [pseudarthrosis]
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Interventions/Observational Groups

  •   chronic osteomyelitis and/ or infected non-unions;
    retrospective analysis of all patients with COM and/ or infected non-unions, who obtained BAG-S53P4 after surgical debridement to fill their bone defects. Follow-up data will be performed during consultation hours or during hospital 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
  •   No
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Primary Outcome

Primary endpoint is the successful control of infection during the follow-up period.
Clinical control of signs of reinfection during consultation hours, as a rule after 6 weeks, 3, 6, 12 and 18 months.
No reexacerbation: no signs of infection (redness, fistula etc) and no reoperations

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Secondary Outcome

Secondary endpoints were the absence of local or systemic reactions due to the implanted BAG (e.g. foreign body reactions, redness, swelling, increased secretion or allergic reactions), the time period to full weight bearing as well as the time period to radiologic detectable incorporation of BAG.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2017/05/05
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Inclusion criteria were the existence of COM and/ or infected non-unions (evidence of positive bacteriology and/ or positive histology of intraoperative removed samples).
Period of treatment/ data analysis: 07/13 - 12/16

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Exclusion Criteria

Exclusion criteria were aseptic non-unions and unavailable follow-up.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • BG Klinikum Duisburg
    • Ms.  Dr. med.  Eva  Steinhausen 
    • Großenbaumer Alle 250
    • 47249  Duisburg
    • Germany
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    • BG Klinikum Duisburg
    • Ms.  Dr. med.  Eva  Steinhausen 
    • Großenbaumer Allee 250
    • 47249  Duisburg
    • Germany
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    • BG Klinikum Duisburg
    • Ms.  Dr. med.  Eva  Steinhausen 
    • Großenbaumer Alle 250
    • 47249  Duisburg
    • Germany
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Sources of Monetary or Material Support

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    • BG Klinikum Duisburg
    • Ms.  Dr. med.  Eva  Steinhausen 
    • Großenbaumer Alle 250
    • 47249  Duisburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/05/20
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Trial Publications, Results and other Documents

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