Who is sponsoring NCT03694925?

NCT03694925 is sponsored by The Cleveland Clinic.

What drugs are being tested in NCT03694925?

Interventions in NCT03694925: Calprotectin test.

What condition does NCT03694925 study?

NCT03694925 studies Prosthetic Joint Infection.

Is NCT03694925 still recruiting?

NCT03694925 is currently completed. Last updated 17 December 2020.

Are results published for NCT03694925?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-12-17 · How we verify

NCT03694925

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Diagnostic Utility of a Novel Point-of-Care Test of Calprotectin for Revision Total Knee Arthroplasty

Completed Results posted Last updated 17 December 2020

What this trial tests

trial testing Calprotectin test in Prosthetic Joint Infection in 156 participants. Completed in 4 March 2020.

Timeline

29 October 2018

Primary endpoint
7 January 2020

4 March 2020

Quick facts

Lead sponsor	The Cleveland Clinic
Status	Completed
Study type	OBSERVATIONAL
Enrollment	156
Start date	29 October 2018
Primary completion	7 January 2020
Estimated completion	4 March 2020
Sites	2 locations across United States

Drugs / interventions tested

Calprotectin test

Conditions studied

Prosthetic Joint Infection — all drugs for Prosthetic Joint Infection →

Sponsor

The Cleveland Clinic

Who can join

18 and older, any sex, with Prosthetic Joint Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Calprotectin POC Primary · Day of surgery

lateral flow point of care test

Positive at >50 mg/L

Group	Value	95% CI
Primary Total Knee Arthroplasty	1
Aseptic Revision Total Knee Arthroplasty	3
Revision Septic Total Knee Arthroplasty	52

Negative at >50 mg/L

Group	Value	95% CI
Primary Total Knee Arthroplasty	29
Aseptic Revision Total Knee Arthroplasty	67
Revision Septic Total Knee Arthroplasty	1

Positive at >14 mg/L

Group	Value	95% CI
Primary Total Knee Arthroplasty	1
Aseptic Revision Total Knee Arthroplasty	9
Revision Septic Total Knee Arthroplasty	52

Negative at >14 mg/L

Group	Value	95% CI
Primary Total Knee Arthroplasty	29
Aseptic Revision Total Knee Arthroplasty	61
Revision Septic Total Knee Arthroplasty	1

Calprotectin ELISA Secondary · Day of surgery

ELISA analysis

Positive at >50 mg/L

Group	Value	95% CI
Primary Total Knee Arthroplasty	1
Aseptic Revision Total Knee Arthroplasty	3
Revision Septic Total Knee Arthroplasty	52

Negative at >50 mg/L

Group	Value	95% CI
Primary Total Knee Arthroplasty	29
Aseptic Revision Total Knee Arthroplasty	67
Revision Septic Total Knee Arthroplasty	1

Positive at >14 mg/L

Group	Value	95% CI
Primary Total Knee Arthroplasty	1
Aseptic Revision Total Knee Arthroplasty	12
Revision Septic Total Knee Arthroplasty	52

Negative at >14 mg/L

Group	Value	95% CI
Primary Total Knee Arthroplasty	29
Aseptic Revision Total Knee Arthroplasty	58
Revision Septic Total Knee Arthroplasty	1

Area Under the Curve Secondary · From completion of first patient's ELISA and POC test to last patient's ELISA and POC test

Area under the curve (AUC) was calculated using receiver operator characteristic (ROC) curve using the two cut offs (\>14 mg/L and \>50 mg/L) for both the ELISA and POC tests. Data were collected intraoperatively during the patient's arthroplasty surgery. AUC - ROC curve is a performance measurement for classification problem at various thresholds settings. ROC is a probability curve and AUC represents degree or measure of separability. It tells how much model is capable of distinguishing between classes. Higher the AUC, better the model is at predicting 0s as 0s (aseptics that are negative)

POC Test >50 mg/L

Group	Value	95% CI
Combined Revision Total Knee Arthroplasty	0.969	0.934 – 1.000

POC Test >14 mg/L

Group	Value	95% CI
Combined Revision Total Knee Arthroplasty	0.926	0.875 – 0.978

ELISA Test >50 mg/L

Group	Value	95% CI
Combined Revision Total Knee Arthroplasty	0.969	0.934 – 1.000

ELISA Test >14 mg/L

Group	Value	95% CI
Combined Revision Total Knee Arthroplasty	0.905	0.847 – 0.962

Sponsor's own description

The purpose of this study is to investigate whether there are quantifiable differences in the level of calprotectin in the synovial fluid that allow separation of different modes of joint implant failure (e.g. infected, aseptic loosening). A subset of primary TKA patients (with history of OA) will be included as a baseline.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Prosthetic Joint Infection

Currently open trials in the same condition.

NCT07107685 — Prosthetic Joint Infection : Lessons From Deceased Patients in Critical Care. · recruiting
NCT06627842 — OsteoArticular Sepsis in Intensive Care unitS · recruiting
NCT04650607 — Phage Safety Cohort Study · recruiting
NCT04858217 — Periprosthetic Joint Infections: Diagnostic Accuracy and Cost-effectiveness Analysis of Serum and Synovial Markers · recruiting
NCT04724603 — Phage Safety Retrospective Cohort Study · recruiting

Other The Cleveland Clinic trials

Trials by the same sponsor.

NCT07218198 — Clinical Decision Support Tool for the Treatment of Uncontrolled Hypertension · NA · not yet recruiting
NCT07442747 — Neural Mechanisms of Aerobic Exercise Benefits in PD With DBS · NA · not yet recruiting
NCT07471464 — Centered Surgery - Preoperative Counseling and Patient Satisfaction · recruiting
NCT07073963 — Virtual Patient Groups for Sarcoidosis Associated Fatigue · NA · recruiting
NCT07363343 — Nifedipine and Enalapril vs Nifedipine and Labetalol for the Treatment of Postpartum Hypertension Study · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03694925 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The Cleveland Clinic
Last refreshed: 17 December 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03694925.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing