Efficacy of Serum ESR, CRP, Synovial Leucocyte Esterase Dipstick Test in The Diagnosis of Chronic Infection in Total Joint Arthroplasty (ESR/CRP/LE pji)

July 18, 2026 updated by: Ain Shams University

The Diagnosis Dilemma: Efficacy of Serum ESR, CRP, Synovial Leucocyte Esterase Dipstick Test in the Diagnosis of Chronic Infection in Total Joint Arthroplasty.

aim of this study was to determine accuracy of using leucocyte esterase (LE),Erythroscyte sedimentation rates (ESR) and C- Reactive protein (CRP) for diagnosing periprosthetic joint infections (PJI)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a Prospective cohort study done on 80 patients and the ICM scoring system was used to assess the status of the patient as regards infection diagnosis as regards the use of Major criteria for infection (Sinus communicating with the joint, 2 positive cultures of the same organism) and minor criteria.

Patients included in the study presented with symptoms and signs and were suspected to have PJI. They had either one of the major criteria for PJI (definite diagnosis) or one or two of the minor criteria. All patients underwent aspiration for synovial LE, cytology, cultures and synovial fluid analysis.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Abbasya
      • Cairo, Abbasya, Egypt, 11566
        • Ain Shams University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Infected and query infected TJR patients Time of presentation >=4 weeks post op.

Exclusion Criteria:

presentation before 4 weeks post op Hematogenous infections Patients with infection elsewhere in the body Patients with inflammatory arthritis as gouty arthritis, SLE and RA.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active / sample arm
patients with pji
Diagnostic test: CRP
serum level of CRP is measured
Diagnostic test: ESR
ESR serum levels are measured
Diagnostic test: Leukocyte esterase dipstick test
LE box within the urinary dipstick test is measured
Active Comparator: control group
control arm
Diagnostic test: CRP
serum level of CRP is measured
Diagnostic test: ESR
ESR serum levels are measured
Diagnostic test: Leukocyte esterase dipstick test
LE box within the urinary dipstick test is measured

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum ESR level
Time Frame: at day 0
(mm/hr)(more than or equal 30mm/hr is considered positive/infected{PJI})
at day 0
serum CRP level
Time Frame: at day 0
(mg/L)(more than or equal 10 mg/L is considered positive/infected{PJI})
at day 0
Synovial Leukocyte esterase dipstick test
Time Frame: at day 0
(Plus 1 or more is considered positive/infected{PJI})
at day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2022

Primary Completion (Actual)

January 5, 2024

Study Completion (Actual)

May 5, 2024

Study Registration Dates

First Submitted

June 29, 2026

First Submitted That Met QC Criteria

July 18, 2026

First Posted (Actual)

July 22, 2026

Study Record Updates

Last Update Posted (Actual)

July 22, 2026

Last Update Submitted That Met QC Criteria

July 18, 2026

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FMASU MD323/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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