Heraeus MicroDTTect Lyon Pilot Studyprosthetic Joint Infections (PJIs)

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

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 Overview

• Status: Completed
• Conditions: Chronic PJIs
• Intervention / Treatment: Biological: Culture of removed prosthesis using DTT

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with painful prosthesis or prosthesis loosening <10 years treated at the CRIOAc Lyon

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Biological: Culture of removed prosthesis using DTT; No specific or supplementary intervention is performed among patients. The included patients have scheduled surgery consisting of prosthesis removal or change. Instead of being discarded, the prosthesis which was removed during the surgery was sent to the laboratory using the MicroDTTect system and bacterial culture was performed with the fluid obtained. Results will be then compared to classical culture of periprosthetic tissues (PPT).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of bacteria isolated isolated	type of bacteria isolated	every day until 15 days of culture

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to positivity of cultures	time to positivity of cultures of the fluid obtained after prosthesis treatment using the MicroDTTect system in comparison with conventional culture of PPT samples	every day until 15 days of culture

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: FREDERIC LAURENT, LAURENT

Publications and helpful links

Helpful Links

• website of CRIOAc Lyon

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2018
• Primary Completion (ACTUAL): September 1, 2019
• Study Completion (ACTUAL): September 1, 2019

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: April 30, 2020
• First Posted (ACTUAL): May 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 1, 2020
• Last Update Submitted That Met QC Criteria: April 30, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: biofilm; implant failure; bone and joint infection; prosthetic joint infection; joint arthroplasty; dithiothreitol
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: 18-265

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No