Calprotectin in Chronic Prosthetic Joint Infection

NCT ID: NCT05060952

Last Updated: 2021-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prosthetic Joint Infection Prosthetic Infection Arthroplasty Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PJI

Patients with septic arthroplasty failure

Calprotectin Lateral Flow Test

Intervention Type DIAGNOSTIC_TEST

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

Aseptic

Patients with aseptic causes of arthroplasty failure

Calprotectin Lateral Flow Test

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Calprotectin Lateral Flow Test

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* acute prosthetic joint infection
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Christian Suren

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Munich, Bavaria, Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Christian Suren, M.D.

Role: CONTACT

+49 89 4140 ext. 2271

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Christian Suren, M.D.

Role: primary

+49 89 4140 ext. 2271

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

26/19 S-SR

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Antibiotic Prophylaxis in High-Risk Arthroplasty Patients
NCT04297592 ENROLLING_BY_INVITATION PHASE4