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This study is a prospective bicentric feasibility study, which aims to evaluate the feasibility of a two-stage full implant exchange with early prosthesis reimplantation between 16 and 30 days after implants removal for hip or knee prosthetic joint infection.
This study concern 50 patients, prospectively included and compared to the last 50 patients with hip or knee PJI managed with classical two-stage implant exchange.
The duration of the study is 42 months.
Prosthetic joint infection (PJI) is a rare but severe complication, with long and complex medico-surgical procedures ang high morbidity. Two-stage full implant exchange is commonly used for PJI, but the best time for prosthesis reimplantation remains unclear. Late reimplantation leads to prolonged immobilization, which can cause decubitus complications and altered joint functionnality.
The hypothesis is that reimplantation between 16 and 30 days after implants removal, earlier than suggested by some relatively old recommandations, associated with 12 weeks antibiotic therapy is a safe and efficient option, allowing shorter immobilization susceptible to improve joint functionnality.
The principal aim of this study is to evaluate the feasibility of a two-stage full implant exchange with early prosthesis reimplantation.
50 patients with knee or hip PJI eligible for two-stage implant exchange will be prospectively included in two french centers.
Surgical procedure will be standardized, with prothesis reimplantation within 16 to 30 days after implants removal, associated with 12 weeks adaptated antibiotherapy according to french recommendations.
Patients will be compared to the last 50 patients with hip or knee PJI managed with classical two-stage implant exchange in these centers until december 2021 (retrospective group).
Follow up consists of 7 clinical evaluations, from inclusion until month15 after prosthesis removal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective group | Experimental | 50 patients prospectively included with early prosthesis reimplantation |
|
| Retrospective group | Other | Last 50 patients with hip or knee prosthetic-joint infection managed with classical two-stage implant exchange |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early prosthesis reimplantation | Procedure | Early prosthesis reimplantation, within 16 to 30 days after implants removal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of eligible patients included and benefiting from the standardized protocol without major deviations | Number of eligible patients having been included in the study having benefited from the standardized protocol without major deviations / number of eligible patients according to surgeons or doctors during consultations and hospitalization in orthopedic or infectious disease departments | At 3 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of eligible patients included | Number of eligible patients included in the study / number of eligible patients according to surgeons or doctors during consultations and hospitalization in orthopedic or infectious disease departments | At 3 months follow-up |
| Rate of clinical cure |
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Inclusion Criteria:
Prospective group:
A Impossibility of conservative treatment : infection occurring more than 4 weeks after prosthesis implantation, fistula, documented resistant germ, loosened prosthesis / B Unsuitable 1-stage change: recurrence after 1-stage management, precarious bone capital, documented resistant microorganism, infection without prior microbiological documentation, fistula, surgeon's assessment in disfavor
- Effective contraception during the research period for fertile women of childbearing age
Retrospective group :
Exclusion Criteria:
Prospective group :
Retrospective group :
- Refusal to participate
Study exit criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nathalie PANSU, MD | Contact | +33467339510 | n-pansu@chu-montpellier.fr | |
| Vincent LE MOING, MD PhD | Contact | +33467339510 | v-le_moing@chu-montpellier.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nathalie PANSU, MD | Infectious Diseases department, Montpellier university hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Montpellier - Hôpital Saint-Eloi | Recruiting | Montpellier | 34090 | France |
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| Retrospective analysis of medical records | Other | Analysis of 50 records of operated patients managed with classical two-stage implant exchange |
|
Number of patients included without signs of infectious relapse to the same germ or persistence of the initial infection at M15 / number of patients included who benefited from the standardized protocol without major deviations., compared to clinical cure rate in retrospective group |
| At 15 months follow-up |
| Rate of re-infection with a different microorganism (superinfection) during follow-up and up to M15 | Number of patients who presented a reinfection according to the EBJIS criteria with a germ different from the initial organism(s) during follow-up / number of patients included who benefited from the standardized protocol without major deviations, compared to reinfection rate in retrospective group | At 15 months follow-up |
| Length of stay | Cumulative length of stay in hospital (medicine or surgery wards) or in follow-up care compared to cumulative length of stay in retrospective group | At 15 months follow-up |
| Articular functionnality | Knee Society Score or Harris Hip Score | At 6 months follow-up |
| Articular functionnality | Knee Society Score or Harris Hip Score | At 15 months follow-up |
| Quality of life auto-evaluation score | EQ-5D-5L score (auto-questionnary) | At inclusion |
| Quality of life auto-evaluation score | EQ-5D-5L score (auto-questionnary) | At 3 months follow-up |
| Quality of life auto-evaluation score | EQ-5D-5L score (auto-questionnary) | At 15 months follow-up |
| Antibiotics tolerance | Evaluation of antibiotics tolerance by clinical +/- biological evaluation | From inclusion to 3 months follow-up |
| CH de Sète - Hôpitaux du bassin de Thau | Recruiting | Sète | 34200 | France |
|