Overview

This trial is active, not recruiting.

Condition bone and joint prosthetic infections
Sponsor Diaxonhit
Start date June 2012
End date May 2014
Trial size 540 participants
Trial identifier NCT02222792, BJI 2

Summary

A national, prospective, open-label, non-interventional, multicentre, controlled study designed to evaluate a diagnostic method in patients undergoing hip, knee or shoulder prosthetic removal regardless of whether or not infection is suspected. Serological test results will have no impact on the therapeutic approach.

Study objective: To evaluate the diagnostic performance of an antibody detection kit for the serological diagnosis of bone and joint prosthetic device infections cause by Staphylococci, Streptococci, Propionibacterium acnes (P. acnes) and Gram-negative bacteria versus the reference method: the bacterial culture of deep intraoperative samples.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective
Arm
The septic patient group will be comprised of patients presenting with bone and joint prosthetic device infection confirmed by intraoperative microbiological culture (at least 2 deep positive samples for the same bacterial strain).
The non-septic patient group will be comprised of prosthetic patients presenting with symptoms of mechanical loosening, and whose deep intraoperative samples have all proved negative
An intermediate group will be comprised of patients with only one deep positive sample.

Primary Outcomes

Measure
Sensitivity and specificity of test BJI 2
time frame: 2 years

Secondary Outcomes

Measure
Interest of test BJI 2
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Male or female patients 2. Patients 18 years of age or older 3. Patient with a bone and joint prosthetic device: total hip prosthesis (THP) or total knee prosthesis (TKP) or total shoulder prosthesis (TSP) 4. Patients with a revision of a failed prosthesis, regardless of the cause and whether septic or not 5. Patients who have not expressed their opposition to the use of their personal medical data and blood samples Exclusion Criteria: 1. Patients already enrolled or clinically reviewed following a relapse 2. Patients with several prostheses requiring at least two revisions during the same surgical procedure 3. Patients for whom the microbiologist and/or doctor responsible for the care refuses that these patients participate in the study 4. HIV+ patients 5. Patients undergoing chemotherapy for a blood disease or solid tumour 6. Patients under guardianship or trusteeship 7. Patients who are expected to be difficult to monitor (life expectancy less than 1 year, or homeless people, foreigner in transit)

Additional Information

Official title Evaluation of the BJI Inoplex 2 Kit for the Multiplex Serological Diagnosis of Bone and Joint Prosthetic Device Infections
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Diaxonhit.