Heraeus MicroDTTect Lyon Pilot Studyprosthetic Joint Infections (PJIs)

Chronic PJIs Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04371068
• Other study ID #: 18-265
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: April 2020
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic PJIs
• Infection

Intervention

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).

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of bacteria isolated isolated	type of bacteria isolated	every day until 15 days of culture
Secondary	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

External Links

•   website of CRIOAc Lyon