NCT05060952

Calprotectin in Chronic Prosthetic Joint Infection

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Technical University of Munich · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Prosthetic Joint Infection
• Prosthetic Infection
• Arthroplasty Complications

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Calprotectin Lateral Flow Test	Semiquantitative point of care photometric assay for the calprotectin level in joint fluid aspirate

Timeline

• Start date: 2019-03-01
• Primary completion: 2023-12-31
• Completion: 2025-12-31
• First posted: 2021-09-29
• Last updated: 2021-09-29

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated device study