BJI Inoplex 2 : Test for Diagnosis of Prosthetic Infections

Evaluation of the BJI Inoplex 2 Kit for the Multiplex Serological Diagnosis of Bone and Joint Prosthetic Device Infections

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.

Study Overview

• Status: Unknown
• Conditions: Bone and Joint Prosthetic Infections

• Study Type: Observational
• Enrollment (Anticipated): 540

Contacts and Locations

Study Locations

• France
  • Boulogne-Billancourt, France, 92100
    • Hopital Ambroise Pare
  • Paris, France, 75012
    • Groupe Hospitalier Diaconesses Croix Saint Simon

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

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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Septic patient group; 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).
Non-septic patient group; 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
Intermediate group; An intermediate group will be comprised of patients with only one deep positive sample.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity of test BJI 2	The diagnostic performance of the test during unique titration.; Sensitivity: estimated from the proportion of septic group patients with an antibody level above the defined threshold antibody concentration.; Specificity: estimated from the proportion of non-septic-group patients with an antibody level less than or equal to the defined threshold antibody concentration.; Positive likelihood ratio.; Negative likelihood ratio.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interest of test BJI 2	To evaluate the diagnostic interest of the BJI Inoplex 2 test in conjunction with the clinical and laboratory data collected: diagnostic strategy and score combining several criteria.; To evaluate the potential medical and economic benefits of using the test: number and cost of joint aspirations or hospital stays that would have been avoided, delayed diagnosis.; To describe the serological outcome after surgery in septic patients.	2 years

Collaborators and Investigators

• Sponsor: Diaxonhit

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): May 1, 2014
• Study Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: August 19, 2014
• First Submitted That Met QC Criteria: August 20, 2014
• First Posted (Estimate): August 21, 2014

Study Record Updates

• Last Update Posted (Estimate): August 21, 2014
• Last Update Submitted That Met QC Criteria: August 20, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Staphylococci, Streptococci, P acnes and Gram-negative bacteria
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: BJI 2