Calprotectin in Chronic Prosthetic Joint Infection

Recruiting

• Conditions: Prosthetic Infection; Arthroplasty Complications; Prosthetic Joint Infection
• Interventions: Diagnostic Test: Calprotectin Lateral Flow Test

• Registration Number: NCT05060952
• Lead Sponsor: Technical University of Munich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Status Verified: 2021-09
• Study First Submitted: 2021-09-19
• Study First Submitted QC: 2021-09-19
• Last Update Submitted: 2021-09-19
• Study First Posted: 2021-09-29
• Last Update Posted: 2021-09-29
• Primary Completion: 2023-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aseptic	Calprotectin Lateral Flow Test	Patients with aseptic causes of arthroplasty failure
PJI	Calprotectin Lateral Flow Test	Patients with septic arthroplasty failure

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of synovial fluid calprotectin	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.

Trial Locations

Locations (1)

Department of Orthopedics and Sports Orthopedics, Klinikum rechts der Isar, Technical University Munich; 🇩🇪 Munich, Bavaria, Germany