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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07718386

Acronym

ESR/CRP/LE pji

Enrollment

Registered

2026-07-22

Start date

2022-12-21

Completion date

2024-05-05

Last updated

2026-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periprosthetic Joint Infection (PJI)

Keywords

PJI

Brief summary

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)

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.

Interventions

DIAGNOSTIC_TESTCRP

serum level of CRP is measured

DIAGNOSTIC_TESTESR

ESR serum levels are measured

DIAGNOSTIC_TESTLeukocyte esterase dipstick test

LE box within the urinary dipstick test is measured

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 23, 2026