European Prosthetic Joint Infection Cohort Study- Hip, Kn... | NCT02424903

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

NCT02424903

Sponsor

Pro-Implant Foundation

Status

Unknown status

Last Update Posted

Apr 23, 2015Estimated

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Prosthesis-related Infections

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015

Primary Completion Date

Apr 2017Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Mar 24, 2015

First Submission Date that Met QC Criteria

Apr 20, 2015

First Posted Date

Apr 23, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2015

Last Update Posted Date

Apr 23, 2015Estimated

Name	Class
Charite University, Berlin, Germany	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
with prosthetic joint infection		Patients admitted for a septic revision surgery
without prosthetic joint infection		Patients admitted for an aseptic revision surgery

Interventions

Not provided

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients admitted to hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maren Engel	Contact	+4930450652417		maren.engel@charite.de
Alessandra Catalina Bardelli	Contact	+4930450552407		alessandra-catalina.bardelli@charite.de

Overall Officials

Name	Affiliation	Role
Andrej Trampuz	Charite University, Berlin, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité, Berlin		Berlin		13353	Germany

Condition Browse Module

MeSH Terms

ID	Term
D016459	Prosthesis-Related Infections
D007239	Infections

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided