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Calprotectin in Chronic Prosthetic Joint Infection

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05060952
Enrollment
500
Registered
2021-09-29
Start date
2019-03-01
Completion date
2025-12-31
Last updated
2021-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty Complications, Prosthetic Infection, Prosthetic Joint Infection

Brief 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.

Interventions

DIAGNOSTIC_TESTCalprotectin Lateral Flow Test

Semiquantitative point of care photometric assay for the calprotectin level in joint fluid aspirate

Sponsors

Technical University of Munich
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* acute prosthetic joint infection

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy of synovial fluid calprotectinIntraoperativelyThe 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.

Countries

Germany

Contacts

Primary ContactChristian Suren, M.D.
christian.suren@tum.de+49 89 4140

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026