Efficacy of Serum ESR, CRP, Synovial Leucocyte Esterase Dipstick Test in The Diagnosis of Chronic Infection in Total Joint Arthroplasty (ESR/CRP/LE pji)
18. juli 2026 opdateret af: 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)
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
80
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Abbasya
-
Cairo, Abbasya, Egypten, 11566
- Ain Shams University Hospitals
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Active / sample arm
patients with pji
|
serum level of CRP is measured
ESR serum levels are measured
LE box within the urinary dipstick test is measured
|
|
Aktiv komparator: control group
control arm
|
serum level of CRP is measured
ESR serum levels are measured
LE box within the urinary dipstick test is measured
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
serum ESR level
Tidsramme: at day 0
|
(mm/hr)(more than or equal 30mm/hr is considered positive/infected{PJI})
|
at day 0
|
|
serum CRP level
Tidsramme: 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
Tidsramme: at day 0
|
(Plus 1 or more is considered positive/infected{PJI})
|
at day 0
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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- Yang F, Zhao C, Huang R, Ma H, Wang X, Wang G, Zhao X. Plasma fibrinogen in the diagnosis of periprosthetic joint infection. Sci Rep. 2021 Jan 12;11(1):677. doi: 10.1038/s41598-020-80547-z.
- Yuan K, Li WD, Qiang Y, Cui ZM. Comparison of procalcitonin and C-reactive protein for the diagnosis of periprosthetic joint infection before revision total hip arthroplasty. Surg Infect (Larchmt). 2015 Apr;16(2):146-50. doi: 10.1089/sur.2014.034. Epub 2015 Feb 6.
- Piper KE, Fernandez-Sampedro M, Steckelberg KE, Mandrekar JN, Karau MJ, Steckelberg JM, Berbari EF, Osmon DR, Hanssen AD, Lewallen DG, Cofield RH, Sperling JW, Sanchez-Sotelo J, Huddleston PM, Dekutoski MB, Yaszemski M, Currier B, Patel R. C-reactive protein, erythrocyte sedimentation rate and orthopedic implant infection. PLoS One. 2010 Feb 22;5(2):e9358. doi: 10.1371/journal.pone.0009358.
- Yu BZ, Fu J, Chai W, Hao LB, Chen JY. Neutrophil to lymphocyte ratio as a predictor for diagnosis of early Periprosthetic joint infection. BMC Musculoskelet Disord. 2020 Oct 27;21(1):706. doi: 10.1186/s12891-020-03704-5.
- Randau TM, Friedrich MJ, Wimmer MD, Reichert B, Kuberra D, Stoffel-Wagner B, Limmer A, Wirtz DC, Gravius S. Interleukin-6 in serum and in synovial fluid enhances the differentiation between periprosthetic joint infection and aseptic loosening. PLoS One. 2014 Feb 21;9(2):e89045. doi: 10.1371/journal.pone.0089045. eCollection 2014.
- Qin L, Li F, Gong X, Wang J, Huang W, Hu N. Combined Measurement of D-Dimer and C-Reactive Protein Levels: Highly Accurate for Diagnosing Chronic Periprosthetic Joint Infection. J Arthroplasty. 2020 Jan;35(1):229-234. doi: 10.1016/j.arth.2019.08.012. Epub 2019 Aug 9.
- Elgeidi A, Elganainy AE, Abou Elkhier N, Rakha S. Interleukin-6 and other inflammatory markers in diagnosis of periprosthetic joint infection. Int Orthop. 2014 Dec;38(12):2591-5. doi: 10.1007/s00264-014-2475-y. Epub 2014 Aug 13.
- Paziuk T, Rondon AJ, Goswami K, Tan TL, Parvizi J. A Novel Adjunct Indicator of Periprosthetic Joint Infection: Platelet Count and Mean Platelet Volume. J Arthroplasty. 2020 Mar;35(3):836-839. doi: 10.1016/j.arth.2019.10.012. Epub 2019 Oct 15.
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- Ghanem E, Antoci V Jr, Pulido L, Joshi A, Hozack W, Parvizi J. The use of receiver operating characteristics analysis in determining erythrocyte sedimentation rate and C-reactive protein levels in diagnosing periprosthetic infection prior to revision total hip arthroplasty. Int J Infect Dis. 2009 Nov;13(6):e444-9. doi: 10.1016/j.ijid.2009.02.017. Epub 2009 May 27.
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- Litao MK, Kamat D. Erythrocyte sedimentation rate and C-reactive protein: how best to use them in clinical practice. Pediatr Ann. 2014 Oct;43(10):417-20. doi: 10.3928/00904481-20140924-10.
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Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
21. december 2022
Primær færdiggørelse (Faktiske)
5. januar 2024
Studieafslutning (Faktiske)
5. maj 2024
Datoer for studieregistrering
Først indsendt
29. juni 2026
Først indsendt, der opfyldte QC-kriterier
18. juli 2026
Først opslået (Faktiske)
22. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. juli 2026
Sidst verificeret
1. december 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- FMASU MD323/2022
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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