Skip to main content
OpenTrials
Completed

NCT Number: NCT07718386

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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Periprosthetic Joint Infection (PJI)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University hospitals

Cairo, Abbasya, 11566, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CRP

Diagnostic Test

serum level of CRP is measured

ESR

Diagnostic Test

ESR serum levels are measured

Leukocyte esterase dipstick test

Diagnostic Test

LE box within the urinary dipstick test is measured

Primary outcomes

  1. serum ESR level

    Time frame: at day 0

    (mm/hr)(more than or equal 30mm/hr is considered positive/infected{PJI})

  2. serum CRP level

    Time frame: at day 0

    (mg/L)(more than or equal 10 mg/L is considered positive/infected{PJI})

  3. Synovial Leukocyte esterase dipstick test

    Time frame: at day 0

    (Plus 1 or more is considered positive/infected{PJI})

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Acronym: ESR/CRP/LE pji

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 22, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.