Calprotectin in Chronic Prosthetic Joint Infection

NCT05060952 | Unknown FDA Device

• 1 other identifier: 26/19 S-SR
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Prosthetic Joint Infection; Prosthetic Infection; Arthroplasty Complications

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

PJI

Patients with septic arthroplasty failure

Diagnostic Test: Calprotectin Lateral Flow Test

Aseptic

Patients with aseptic causes of arthroplasty failure

Diagnostic Test: Calprotectin Lateral Flow Test

Interventions

Calprotectin Lateral Flow Test DIAGNOSTIC_TEST

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

Aseptic; PJI

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with painful or failed arthroplasty of the hip or knee joint scheduled for partial or complete arthroplasty exchange.

You may qualify if:

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

You may not qualify if:

• acute prosthetic joint infection

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Department of Orthopedics and Sports Orthopedics, Klinikum rechts der Isar, Technical University Munich

Munich, Bavaria, 81675, Germany

RECRUITING

Central Study Contacts

Christian Suren, M.D.

CONTACT

+49 89 4140; christian.suren@tum.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 19, 2021
• First Posted: September 29, 2021
• Study Start: March 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)