Calprotectin in Chronic Prosthetic Joint Infection

September 19, 2021 updated by: Christian Suren, Technical University of Munich

Synovial Fluid Calprotectin Lateral Flow Test for the Diagnosis of Prosthetic Joint Infection

A bacterial infection of an artificial joint is a serious complication that often requires additional surgery to exchange the arthroplasty. It is also difficult to recognize an infected joint, as the symptoms caused by the infection are very similar to those of other problems with arthroplasties, such as loosening of the implant. To improve the ability to diagnose prosthetic joint infections, this study compares the levels of calprotectin, a specific inflammatory protein, in the joint fluid of infected joints and joints with other complications. The underlying hypothesis is that the level of calprotectin in infected joints is significantly higher, thus facilitating the diagnosis of prosthetic joint infection.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 81675
        • Recruiting
        • Department of Orthopedics and Sports Orthopedics, Klinikum rechts der Isar, Technical University Munich
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with painful or failed arthroplasty of the hip or knee joint scheduled for partial or complete arthroplasty exchange.

Description

Inclusion Criteria:

  • scheduled arthroplasty exchange for any of the following reasons:
  • infection
  • loosening
  • instability
  • malalignment
  • periprosthetic fracture

Exclusion Criteria:

  • acute prosthetic joint infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PJI
Patients with septic arthroplasty failure
Diagnostic test: Calprotectin Lateral Flow Test
Semiquantitative point of care photometric assay for the calprotectin level in joint fluid aspirate
Aseptic
Patients with aseptic causes of arthroplasty failure
Diagnostic test: Calprotectin Lateral Flow Test
Semiquantitative point of care photometric assay for the calprotectin level in joint fluid aspirate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of synovial fluid calprotectin
Time Frame: Intraoperatively
The level of synovial fluid calprotectin measured in joint fluid aspirate as a diagnostic test for prosthetic joint infection. The accuracy is calculated by comparing its results with the International Consensus Meeting (ICM) on prosthetic joint infection criteria of 2018.
Intraoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

September 19, 2021

First Submitted That Met QC Criteria

September 19, 2021

First Posted (Actual)

September 29, 2021

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 19, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26/19 S-SR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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