Clinical trial NCT04371068: Heraeus MicroDTTect Lyon Pilot Studyprosthetic Joint Infections (PJIs)
Official title: Evaluation of the microDTTect Device (Heraeus) in the Diagnosis of Low-grade Chronic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic PJIs
Keywords: bone and joint infection
biofilm
joint arthroplasty
implant failure
prosthetic joint infection
dithiothreitol
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with painful prosthesis or prosthesis loosening \<10 years treated at the CRIOAc 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of bacteria isolated isolated
timeFrame: every day until 15 days of culture
Secondary outcomes:
measure: time to positivity of cultures
timeFrame: every day until 15 days of culture
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: LAURENT
name: FREDERIC LAURENT
role: PRINCIPAL_INVESTIGATOR
References: