Bone and Joint Prosthetic Infections Clinical Trial
Official title:
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.
| Status | Active, not recruiting |
| Enrollment | 540 |
| Est. completion date | July 2016 |
| Est. primary completion date | May 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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) |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Ambroise Paré | Boulogne-Billancourt | |
| France | Groupe hospitalier Diaconesses Croix Saint Simon | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Diaxonhit |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | No |