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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05060952
Other study ID # 26/19 S-SR
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2019
Est. completion date December 31, 2025

Study information

Verified date September 2021
Source Technische Universität München
Contact Christian Suren, M.D.
Phone +49 89 4140
Email christian.suren@tum.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 31, 2025
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - scheduled arthroplasty exchange for any of the following reasons: - infection - loosening - instability - malalignment - periprosthetic fracture Exclusion Criteria: - acute prosthetic joint infection

Study Design


Intervention

Diagnostic Test:
Calprotectin Lateral Flow Test
Semiquantitative point of care photometric assay for the calprotectin level in joint fluid aspirate

Locations

Country Name City State
Germany Department of Orthopedics and Sports Orthopedics, Klinikum rechts der Isar, Technical University Munich Munich Bavaria

Sponsors (1)

Lead Sponsor Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic accuracy of synovial fluid calprotectin 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
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