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

• Conditions: Prosthesis-related Infections

• Registration Number: NCT02424903
• Lead Sponsor: Pro-Implant Foundation

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 Timeline

• Study First Submitted: 2015-03-24
• Status Verified: 2015-04
• Study First Submitted QC: 2015-04-20
• Last Update Submitted: 2015-04-20
• Study First Posted: 2015-04-23
• Last Update Posted: 2015-04-23
• Study Start: 2015-05
• Primary Completion: 2017-04
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5000

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Charité, Berlin; 🇩🇪 Berlin, Germany