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Heraeus MicroDTTect Lyon Pilot Studyprosthetic Joint Infections (PJIs)

Completed
Conditions
Chronic PJIs
Interventions
Biological: Culture of removed prosthesis using DTT
Registration Number
NCT04371068
Lead Sponsor
Hospices Civils de Lyon
Brief Summary

Prosthetic joint infections (PJIs) are one of the main causes of implant failure after joint arthroplasty. Identification of the causal organism is crucial for successful treatment. However, microbiological diagnosis of PJIs remains a challenge notably because bacteria are embedded in biofilm adhered to the material. Recently, dithiothreitol (DTT) treatment of prosthesis has been proposed as a new strategy to dislodge bacteria from biofilm, thus becoming an alternative to sonication to improve the yield of the microbiological diagnosis.

In this study, the investigators evaluate the interest of a commercial device using DTT, the MicroDTTect system (Heraeus, Hanau, Allemagne), for the diagnosis of low-grade chronic PJIs compared to the conventional culture of periprosthetic tissue (PPT) samples.

Detailed Description

Prosthetic joint infections (PJIs) are one of the main causes of implant failure after joint arthroplasty. Identification of the causal organism is crucial for successful treatment. However, microbiological diagnosis of PJIs remains a challenge notably because bacteria are embedded in biofilm adhered to the material. Recently, dithiothreitol (DTT) treatment of prosthesis has been proposed as a new strategy to dislodge bacteria from biofilm, thus becoming an alternative to sonication to improve the yield of the microbiological diagnosis.

In this study, the investigators evaluate the interest of a commercial device using DTT, the MicroDTTect system (Heraeus, Hanau, Allemagne), for the diagnosis of low-grade chronic PJIs compared to the conventional culture of periprosthetic tissue (PPT) samples.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
20
Inclusion Criteria

Adult patients with painful prosthesis or prosthesis loosening <10 years

  • without mechanical explanation,
  • without clinical evidence of infection (no fistula, no abscess, no discharge, no local inflammation),
  • without microbiological diagnosis (absence of preoperative joint puncture (not performed or not feasible) or with a culture-negative preoperative joint puncture).
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Exclusion Criteria

Patients with painful prosthesis or prosthesis loosening

  • with mechanical explanation,
  • or with clinical evidence of infection (fistula, abscess, discharge, local inflammation),
  • with a previous microbiological diagnosis
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Patients suspected of low-grade PJIsCulture of removed prosthesis using DTTAdult patients suspected of low-grade PJIs, who have a scheduled prosthesis removal or change and who meet the inclusion criteria
Primary Outcome Measures
NameTimeMethod
Rate of bacteria isolated isolatedevery day until 15 days of culture

type of bacteria isolated

Secondary Outcome Measures
NameTimeMethod
time to positivity of culturesevery day until 15 days of culture

time to positivity of cultures of the fluid obtained after prosthesis treatment using the MicroDTTect system in comparison with conventional culture of PPT samples

Trial Locations

Locations (1)

Hospices Civils de Lyon

🇫🇷

Lyon, France

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