NCT02424903

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 23, 2015

Completed
8 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 23, 2015

Status Verified

April 1, 2015

Enrollment Period

1.9 years

First QC Date

March 24, 2015

Last Update Submit

April 20, 2015

Conditions

Prosthesis-related Infections

Keywords

infectionprosthesishipkneeshoulder

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • Functional outcome

    12 months after surgery

  • lifequality evaluation

    12 months after surgery

Study Arms (2)

with prosthetic joint infection

Patients admitted for a septic revision surgery

without prosthetic joint infection

Patients admitted for an aseptic revision surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients admitted to hospital

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité, Berlin

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Prosthesis-Related InfectionsInfections

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Andrej Trampuz

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maren Engel

CONTACT

+4930450652417maren.engel@charite.de

Alessandra Catalina Bardelli

CONTACT

+4930450552407alessandra-catalina.bardelli@charite.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2015

First Posted

April 23, 2015

Study Start

May 1, 2015

Primary Completion

April 1, 2017

Study Completion

December 1, 2018

Last Updated

April 23, 2015

Record last verified: 2015-04

Locations

DE(1)