Heraeus MicroDTTect Lyon Pilot Studyprosthetic Joint Infections (PJIs)
- 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
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).
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients suspected of low-grade PJIs Culture of removed prosthesis using DTT Adult patients suspected of low-grade PJIs, who have a scheduled prosthesis removal or change and who meet the inclusion criteria
- Primary Outcome Measures
Name Time Method Rate of bacteria isolated isolated every day until 15 days of culture type of bacteria isolated
- Secondary Outcome Measures
Name Time Method time to positivity of cultures every 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