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

Prosthesis-related Infections Clinical Trial

— EPJIC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02424903
• Other study ID #: PJI04/2014
• Status: Not yet recruiting
• Phase: N/A
• First received: March 24, 2015
• Last updated: April 20, 2015
• Start date: May 2015
• Est. completion date: December 2018

Study information

• Verified date: April 2015
• Source: Pro-Implant Foundation
• Contact: Maren Engel
• Phone: +4930450652417
• Email: maren.engel[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5000
• Est. completion date: December 2018
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Prosthesis-Related Infections

Locations

Country	Name	City	State
Germany	Charité, Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Pro-Implant Foundation	Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	lifequality evaluation	by EQ5D5l-score	12 months after surgery	No