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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of test BJI 2 | The diagnostic performance of the test during unique titration.
| 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Interest of test BJI 2 |
|
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Ambroise Paré | Boulogne-Billancourt | 92100 | France | |||
| Groupe hospitalier Diaconesses Croix Saint Simon |
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Serologic assays of sera collected from septic or non-septic patients will be performed in series and operators will be blind in terms of clinical and microbiological status in order to avoid any interpretation bias due to information collected in advance
| 2 years |
| Paris |
| 75012 |
| France |