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Clinical Trials/NCT04371068
NCT04371068
Completed
Not Applicable

Evaluation of the microDTTect Device (Heraeus) in the Diagnosis of Low-grade Chronic

Hospices Civils de Lyon1 site in 1 country20 target enrollmentMarch 1, 2018
ConditionsChronic PJIs

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic PJIs
Sponsor
Hospices Civils de Lyon
Enrollment
20
Locations
1
Primary Endpoint
Rate of bacteria isolated isolated
Status
Completed
Last Updated
6 years ago

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2018
End Date
September 1, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eugénie MABRUT

clinical research assistant

Hospices Civils de Lyon

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

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)

Study Sites (1)

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