Prosthetic Joint Infection
Conditions
Keywords
Prosthesis, joint infection, perioperative samples
Brief summary
Chronic prosthetic joint infection (PJI) is a devastating complication of arthroplasty and its treatment continues to fuel the debate on how to manage it appropriately. One stage and two stage exchange surgery both are the conventional surgical procedures for chronic PJI commonly used to date. Two stage surgery disadvantages (major surgery, anesthesia and nosocomial risks, functional impairment between surgeries and a high socio-economic coast) encouraged many surgical teams to adopt one stage exchange surgery which provides equivalent or better outcomes. However one stage surgery encounters a major conceptual difficulty when it comes to implant the new prosthesis in a surgical site microbiologically undetermined and potentially contaminated. Investigators suppose the new prosthesis is implanted in a contaminated setting regardless of bacteria type and antibiotic therapy duration before arthroplasty. The total lack of data answering this question motivated the conception of this prospective study in order to describe the microbiological setting where is implanted the new prosthesis with one stage exchange surgery after surgical excision and antibiotic therapy initiation in chronic PJI.
Detailed description
Study duration: Two weeks. Recruitment period: 18 months. Maximal duration of data collection: Two weeks. Investigator center: monocenter study. Mean patient inclusion per year: 70 patients per year.
Interventions
PROCEDUREintraoperative samples
Sponsors
Groupe Hospitalier Diaconesses Croix Saint-Simon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient consent * Aged over 18 years * PJI documented preoperatively by joint fluid culture according to Musculoskeletal Infection Society Definition * Monoarticular PJI * PJI management validated at the weekly cross-disciplinary conciliation meeting * PJI treated with one stage surgery and intravenous antibiotherapy adjusted to preoperative aspiration results.
Exclusion criteria
* patient who does not meet eligibility criteria * Negative preoperative aspiration culture * PJI du to fungi * Patient lawfully deprived of his liberty * Patient insured under social security scheme
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of patients with positive per-operative sample culture after surgical excision and antibiotic initiation and prior prosthesis implantation | 18 months | In routine care procedure for prosthetic joint infection (PJI), at least, five intraoperative samples are taken before debridement and prosthesis removal in order to identify the causative organism. For the purpose of this study three additional intraoperative samples will be performed after debridement and antibiotic initiation and prior prosthesis implantation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Description of microbiological evolution of preoperative and perioperative samples before and after surgical excision. | 18 months | In routine care procedure for prosthetic joint infection (PJI), at least, five intraoperative samples are taken before debridement and prosthesis removal in order to identify the causative organism. For the purpose of this study three additional intraoperative samples will be performed after debridement and antibiotic initiation and prior prosthesis implantation. |
| Description of outcomes of perioperative sample culture after surgical excision according to the identified germ in culture before excision. | 18 months | In routine care procedure for prosthetic joint infection (PJI), at least, five intraoperative samples are taken before debridement and prosthesis removal in order to identify the causative organism. For the purpose of this study three additional intraoperative samples will be performed after debridement and antibiotic initiation and prior prosthesis implantation. |
| Description of outcomes of perioperative sample culture after surgical excision according to antibiotherapy duration from initiation until perioperative samples. | 18 months | In routine care procedure for prosthetic joint infection (PJI), at least, five intraoperative samples are taken before debridement and prosthesis removal in order to identify the causative organism. For the purpose of this study three additional intraoperative samples will be performed after debridement and antibiotic initiation and prior prosthesis implantation. |
| Description of outcomes of perioperative sample culture prior surgical excision in patients treated with preoperative antibiotherapy. | 18 months | In routine care procedure for prosthetic joint infection (PJI), at least, five intraoperative samples are taken before debridement and prosthesis removal in order to identify the causative organism. For the purpose of this study three additional intraoperative samples will be performed after debridement and antibiotic initiation and prior prosthesis implantation. |
| Description of outcomes of perioperative sample culture according to symptoms duration prior surgery. | 18 months | In routine care procedure for prosthetic joint infection (PJI), at least, five intraoperative samples are taken before debridement and prosthesis removal in order to identify the causative organism. For the purpose of this study three additional intraoperative samples will be performed after debridement and antibiotic initiation and prior prosthesis implantation. |
Countries
France
Outcome results
None listed