European Prosthetic Joint Infection Cohort Study- Hip, Knee and Shoulder Prosthetic Joint Infection

Study Overview
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Brief Summary
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The purpose of the study is to compare different approaches for the treatment of prosthetic joint revisions and to optimize the outcomes in patients with prosthetic joint infections (PJI) by improving the treatment concept of PJI.

Detailed Description
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The aim of the study is to assess the impact of different surgical and antibiotic therapies on patients admitted for a septic or aseptic revision of the hip, knee or shoulder prosthesis. The decision whether the implant will be retained or removed or antimicrobial treatment is based on criteria of each participating center specialists.The success of different treatment algorithms will be measured in terms of infection free interval, functional outcome and quality of life. All consecutive patients who need a revision surgery to the hip, knee or shoulder will be included. Furthermore the study will investigate different diagnostic tests (microbiological and histological) for the diagnosis and the discrimination of septic and aseptic causes in prosthesis failures. Pathogens (microorganisms isolated from puncture of the joint, tissue samples sonication fluid and blood) will be collected to establish a biobank.The samples are obtained preoperatively and intraoperatively as part of routine care practice. The study is not randomized.

Official Title
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European Prosthetic Joint Infection Cohort Study (EPJIC): Evaluation of the Treatment Approach for Hip, Knee and Shoulder Prosthetic Joint Revision Surgery

Conditions
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Prosthesis-related Infections

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subject is older than 18 years of Age written informed consent has been obtained subject Needs a Revision surgery of the hip, knee or shoulder prosthesis Exclusion Criteria: subject is currently enrolled in another investigational study inability to read and understand the participant's Information subject is younger than 18 years of age

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| with prosthetic joint infection<br>Patients admitted for a septic revision surgery | |
| without prosthetic joint infection<br>Patients admitted for an aseptic revision surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection outcome | The infection-free status is defined as absence of clinical (e.g. no fistula), laboratory (e.g. normal C-reactive protein) and radiological signs of infection (e.g. no septic loosening). | 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcome | by HARRIS HIP SCORE, CONSTANT SHOULDER SCORE, KNEE SOCIETY SCORE, OXFORD HIP SCORE, OXFORD KNEE SCORE, QUICK DASH SCORE | 12 months after surgery | 
| lifequality evaluation | by EQ5D5l-score | 12 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infection, prosthesis, hip, knee, shoulder