- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03694925
Diagnostic Utility of a Novel Point-of-Care Test of Calprotectin for Revision Total Knee Arthroplasty
Diagnostic Utility of a Novel Point-of-Care Test of Calprotectin for Revision Total
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Calprotectin is a biomarker closely associated with leucocytes in general, and is present in high volumes in neutrophil cells. Calprotectin is also produced by infiltrating monocytes and macrophages, where calprotectin is released upon phagocytosis. In neutrophils, calprotectin is stored intracellularly and are released upon activation of the cell. The determination of number of neutrophils and proportion of neutrophils out of total number of inflammatory cells is a diagnostic strategy commonly used in diagnosis of infection. Upon encounter with a pathogen, neutrophils have several strategies to fight infections , and produce high-levels of calprotectin. Activation of neutrophils, and release of calprotectin, can be for any reason causing activation of the complement system and aseptic Inflammatory responses. Moreover, Calprotectin is a danger associated molecular patterns (DAMP) signal influencing the inflammatory responses. The level of activated neutrophils in PJI provide basis of the presence of calprotectin in the synovial fluid of PJI patients, and thus, for calprotectin as a potential biomarker for PJI. Calprotectin-levels in the synovial fluid do not merely reflect the level of leucocytes and neutrophils present in the synovial fluid, but levels are correlated to the WBC content. Calprotectin is likely to reflect the number of activated cells and surpass the diagnostic accuracy of total WBC counts and neutrophil percentage for PJI diagnosis.
A level of calprotectin of 50 mg/L in the synovial fluid has very good diagnostic accuracy for PJI, supported by area under the curve values of more than 0.9. In a subgroup analysis for patients with chronic PJI, a NPV of 97% was observed. The excellent NPV may assist in the orthopaedic clinic to rule out the presence of infection and consider diagnostic alternatives for aseptic loosening and pain revision of the joint patient. A rapid and accurate distinction between these two causes is important as PJI and aseptic loosening are managed differently with regards to surgical Intervention and followup.
Point of Care Test diagnostics by lateral flow devices provides reliable test results within minutes of sample collection. Currently, Calprotectin can be detected by such lateral flow devices (developed by Orthogenics, Tromsø, Norway). The speed and ease of use of this test allows for diagnosis at patient's bed side. These tests can be applied in the physician's office, operating room, an ambulance, the home, the field, or in the hospital. As the results are timely they allow rapid diagnostic and identifies treatment alternatives for the patient. This technology empowers clinicians to make decisions at the "point-of-care" and can have significant impact on health care delivery and ability to address challenges of health disparities. However, it is important to validate the diagnostic utility of calprotectin POC in a diverse set of patients undergoing revision arthroplasty.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Florida
-
Weston, Florida, United States, 33331
- Cleveland Clinic Florida
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Three groups:
Primary total knee arthroplasty Aseptic revision total knee arthroplasty Septic revision total knee arthroplasty
Description
Inclusion Criteria:
- Subject is ≥18 years of age
- Patient with a diagnosis of OA (for primary TKA only)
- Subject has had no recent injections or surgeries of the joint (within past 6 weeks)
- Subject has or will have all of the medical tests required to allow MSIS classification
- Subject signs informed consent form
Exclusion Criteria:
- Subjects with a diagnostic synovial fluid specimen collection within the past 7 days
- Results are not available for medical tests required to perform MSIS classification
- Sample was obtained via lavage
- Quantity not sufficient (at least 1 ml required)
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Primary total knee arthroplasty
Primary TKA patients included in the study, to provide a baseline level for calprotectin.
|
Calprotectin will be measured both by ELISA and point of care test.
|
Aseptic revision total knee arthroplasty
Aseptic revision TKA patients included in the study.
These are patients who are not considered infected according to Musculoskeletal Infection Society criteria for infection.
|
Calprotectin will be measured both by ELISA and point of care test.
|
Revision septic total knee arthroplasty
Septic revision TKA patients included in the study.
These are patients who are considered infected according to Musculoskeletal Infection Society criteria for infection.
|
Calprotectin will be measured both by ELISA and point of care test.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Calprotectin POC
Time Frame: Day of surgery
|
lateral flow point of care test
|
Day of surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Calprotectin ELISA
Time Frame: Day of surgery
|
ELISA analysis
|
Day of surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carlos Higuera, MD, The Cleveland Clinic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 18-882
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prosthetic Joint Infection
-
Charite University, Berlin, GermanyUnknownHip Prosthetic Joint Infection | Knee Prosthetic Joint Infection | Shoulder Prosthetic Joint Infection
-
Osteal Therapeutics, Inc.Active, not recruitingProsthetic-joint InfectionUnited States
-
Vivantes Netzwerk für Gesundheit GmbHUnknownProsthetic Joint Infection | Infections Joint Prosthetic | Wear of Articular Bearing Surface of Internal Prosthetic Joint | Infection Prosthetic | Prosthetic PainGermany
-
University Hospital, Basel, SwitzerlandActive, not recruitingProsthetic-joint InfectionSwitzerland
-
University Hospital, MontpellierNot yet recruitingProsthetic-joint Infection
-
Osteal Therapeutics, Inc.AvailableProsthetic-joint Infection
-
University Hospital, ToursPfizer; International Clinical Trials AssociationUnknownEfficacy and Safety Study of Antibiotic Treatment to Treat Hip Prosthetic Joint Infection (LIZ-BONE)Hip Prosthetic Joint InfectionFrance, Spain, Italy
-
Leiden University Medical CenterRadboud University Medical Center; University Medical Center Groningen; Erasmus... and other collaboratorsRecruitingProsthetic-joint Infection | Infection Hip | Infection; Knee, JointNetherlands
-
Assistance Publique - Hôpitaux de ParisNot yet recruiting
-
Technical University of MunichUnknownDiagnosis Prosthetic Joint InfectionGermany
Clinical Trials on Calprotectin test
-
Technical University of MunichRecruitingProsthetic Joint Infection | Arthroplasty Complications | Prosthetic InfectionGermany
-
Bühlmann Laboratories AGCompleted
-
King's College Hospital NHS TrustCompletedInflammatory Bowel Diseases | Crohn's Disease | Ulcerative Colitis
-
Mahidol UniversityCompletedColorectal Cancer | Colitis | Colorectal AdenomaThailand
-
Ferring PharmaceuticalsCompletedMild-to-moderate Ulcerative ColitisPoland, Hungary, Italy, Czechia, Netherlands, Slovakia
-
Sisli Hamidiye Etfal Training and Research HospitalCompletedNAFLD | Obesity, ChildhoodTurkey
-
Kyungpook National University HospitalCompletedUlcerative ColitisKorea, Republic of
-
Fondazione Policlinico Universitario Agostino Gemelli...Completed
-
Parc de Salut MarCompletedColonic Neoplasms | Diverticulitis, ColonicSpain