European Prosthetic Joint Infection Cohort Study (EPJIC): Evaluation of the Treatment Approach for Hip, Knee and Shoulder Prosthetic Joint Revision Surgery
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Pro-Implant Foundation
- Enrollment
- 5,000
- Locations
- 1
- Primary Endpoint
- Infection outcome
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Infection outcome
Time Frame: 12 months after surgery
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).
Secondary Outcomes
- Functional outcome(12 months after surgery)
- lifequality evaluation(12 months after surgery)