Calprotectin in Chronic Prosthetic Joint Infection

Arthroplasty Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05060952
• Other study ID #: 26/19 S-SR
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Arthritis, Infectious
• Arthroplasty Complications
• Communicable Diseases
• Infections
• Prosthetic Infection
• Prosthetic Joint Infection

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