Trial document




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  DRKS00009696

Trial Description

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Title

Microbiologic evaluation of remnants of jetting fluids in the surgical field over time

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Infection of total knee arthroplasty (TKA) is a disaster for the patients and can be followed by a long life of suffering. Thus, all possible risk factors should be minimized or diminished. One cause of infection is the contamination during surgery. During surgery, the open field is often cleaned with water-kind fluids. These fluids collect in the surgical field and on the surgical wrapping. Together with body fluids such as blood as well as body tissue, this is a good environment for bacteria growth. Aim of the current study is to evaluate bacteria growth in these fluids during surgery at different time points. Thus during surgery, at fixed time points samples of these fluids will be collected and checked for bacteria in a laboratory. Furthermore, patients will be contacted after 1, 5, 10 and 20 years regarding TKA infections and the exact species of the bacteria. This will help to better understand which contamination leads to an infection.
In one center, primary TKAs will be evaluated. In the other center, revision TKAs (except TKAs with known previous infections).

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Brief Summary in Scientific Language

At the beginning of the surgery (TKA implantation), two sample of fluids will be collected each from one of the fluid bags to exclude contamination through the original fluid used during surgery. One of these two sample will be collected from the fluid bag used for the jet lavage, and the other sample will be collected from the fluid bag used for 20ml syringes for lavages. Afterwards, a sample of fluid will be splashed over the surgical field (before skin incision) and a sample will be harvested (about 2-3ml) for microbiological evaluation. Then, each 30min one sample of fluid from the surgical cover will be collected, the last one at the end of surgery. After the surgery is finished, the tip of the suction will also be send into the microbiological laboratory. In case, there is no or to less fluid on the surgical cover, this will be noted in the protocol. Each sample will be added into a children blood culture bottle for transportation into the microbiological laboratory.
Two microbiologic laboratories (one for Wriezen and one for Berlin) will culture the samples at least 14 days. In case of a bacteria growth the exact bacteria species will be determined and a resistogram established. Furthermore, patients will contacted after 1, 5, 10 and 20 years regarding an infection of their TKA meanwhile.
In one center, primary TKAs will be evaluated. In the other center, revision TKAs (except with previous infection) will be evaluated.

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Organizational Data

  •   DRKS00009696
  •   2016/02/24
  •   [---]*
  •   yes
  •   Approved
  •   S20(a)/2015, Ethik-Kommission der Landesärztekammer Brandenburg
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Secondary IDs

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Health Condition or Problem studied

  •   M17.1 -  Other primary gonarthrosis
  •   T84.5 -  Infection and inflammatory reaction due to internal joint prosthesis
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Interventions/Observational Groups

  •   patients with primary osteoarthritis of the knee who receive a primary total knee arthroplasty
  •   patients who receive a one-stage, aseptic revision total knee arthroplasty
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

evidence of a contamination with bacteria in one of the samples

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Secondary Outcome

Secondary endpoints are in case of a contamination:
- identification of the specific bacteria,
- resistogram,
- postoperative knee infection after 1, 5, 10 and 20 years

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2016/03/22
  •   200
  •   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

patients with primary total knee arthroplasty and patients with one-stage aseptic total knee arthroplasty revision surgery (excluded preoperative infection). signed informed consent of the patients.

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Exclusion Criteria

Patients with limited contractual capability. Patients < 18 years. Patients scheduled for primary total knee arthroplasty with implants from previous surgeries e.g. plates. For revision TKA patients, patients with previous knee infections will be excluded.

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Addresses

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    • Krankenhaus MOL, Standort Wriezen
    • Mr.  Dr. med.  Hagen  Hommel 
    • Sonnenburger Weg 3
    • 16269  Wriezen
    • Germany
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    • Centrum für Muskuloskeletale Chirurgie, Charité - Universitätsmedizin Berlin
    • Mr.  Dr. med.  Sebastian  Kopf 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Krankenhaus MOL, Standort Wriezen
    • Mr.  Dr. med.  Hagen  Hommel 
    • Sonnenburger Weg 3
    • 16269  Wriezen
    • Germany
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    • Krankenhaus MOL, Standort Wriezen
    • Mr.  Dr. med.  Hagen  Hommel 
    • Sonnenburger Weg 3
    • 16269  Wriezen
    • Germany
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Sources of Monetary or Material Support

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    • Centrum für Muskuloskeletale Chirurgie, Charité - Universitätsmedizin Berlin
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Klinik für Orthopädie, Krankenhaus Märkisch-Oderland, Standort Wriezen
    • Sonnenburger Weg 3
    • 16269  Wriezen
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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