Heraeus MicroDTTect Lyon Pilot Studyprosthetic Joint Infections (PJIs)

Civil Hospices of Lyon

Status: Completed

Conditions: Chronic PJIs

Treatments: Biological: Culture of removed prosthesis using DTT

Study type: Observational

Funder types: Other

Identifiers

NCT04371068

18-265

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

Patients suspected of low-grade PJIs

Description:

Adult patients suspected of low-grade PJIs, who have a scheduled prosthesis removal or change and who meet the inclusion criteria

Treatment:

Biological: Culture of removed prosthesis using DTT