Evaluation of the microDTTect Device (Heraeus) in the Diagnosis of Low-grade Chronic
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Rate of bacteria isolated isolated
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
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
Outcomes
Primary Outcomes
Rate of bacteria isolated isolated
Time Frame: every day until 15 days of culture
type of bacteria isolated
Secondary Outcomes
- time to positivity of cultures(every day until 15 days of culture)
Investigators
Eugénie MABRUT
clinical research assistant
Hospices Civils de Lyon