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

Pro-Implant Foundation

Status: Unknown

Conditions: Prosthesis-related Infections

Study type: Observational

Funder types: Other

Identifiers

NCT02424903

PJI04/2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

5,000 participants in 2 patient groups

with prosthetic joint infection

Description:

Patients admitted for a septic revision surgery

without prosthetic joint infection

Description:

Patients admitted for an aseptic revision surgery