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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02424903

Acronym

EPJIC

Enrollment

5000

Registered

2015-04-23

Start date

2015-05-31

Completion date

2018-12-31

Last updated

2015-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prosthesis-related Infections

Keywords

infection, prosthesis, hip, knee, shoulder

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Infection outcome	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

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

Countries

Germany

Contacts

Primary ContactMaren Engel

maren.engel@charite.de+4930450652417

Backup ContactAlessandra Catalina Bardelli

alessandra-catalina.bardelli@charite.de+4930450552407

Outcome results