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

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

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.

Study Overview

• Status: Unknown
• Conditions: Prosthesis-related Infections

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 Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

• Study Contact: Name: Maren Engel; Phone Number: +4930450652417; Email: maren.engel@charite.de
• Study Contact Backup: Name: Alessandra Catalina Bardelli; Phone Number: +4930450552407; Email: alessandra-catalina.bardelli@charite.de

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Charité, Berlin
    • Contact: Maren Engel; Phone Number: +4930450652417; Email: maren.engel@charite.de
    • Contact: Alessandra Catalina Bardelli; Phone Number: +4930450552407; Email: alessandra-catalina.bardelli@charite.de
    • Principal Investigator: Andrej Trampuz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients admitted to hospital

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
with prosthetic joint infection; Patients admitted for a septic revision surgery
without prosthetic joint infection; Patients admitted for an aseptic revision surgery

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pro-Implant Foundation
• Collaborators: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Andrej Trampuz, Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): April 1, 2017
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: March 24, 2015
• First Submitted That Met QC Criteria: April 20, 2015
• First Posted (Estimate): April 23, 2015

Study Record Updates

• Last Update Posted (Estimate): April 23, 2015
• Last Update Submitted That Met QC Criteria: April 20, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: knee; infection; prosthesis; shoulder; hip
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Infections; Communicable Diseases; Prosthesis-Related Infections
• Other Study ID Numbers: PJI04/2014