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

NCT07718386 | Completed DMC

• 1 other identifier: FMASU MD323/2022
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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)

Conditions

Periprosthetic Joint Infection (PJI)

Keywords

PJI

Outcome Measures

Primary Outcomes (3)

• serum ESR level

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

  at day 0

• serum CRP level

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

  at day 0

• Synovial Leukocyte esterase dipstick test

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

  at day 0

Study Arms (2)

Active / sample arm

EXPERIMENTAL

patients with pji

Diagnostic Test: CRP; Diagnostic Test: ESR; Diagnostic Test: Leukocyte esterase dipstick test

control group

ACTIVE COMPARATOR

control arm

Diagnostic Test: CRP; Diagnostic Test: ESR; Diagnostic Test: Leukocyte esterase dipstick test

Interventions

CRP DIAGNOSTIC_TEST

serum level of CRP is measured

Active / sample arm; control group

ESR DIAGNOSTIC_TEST

ESR serum levels are measured

Active / sample arm; control group

Leukocyte esterase dipstick test DIAGNOSTIC_TEST

LE box within the urinary dipstick test is measured

Active / sample arm; control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University hospitals

Cairo, Abbasya, 11566, Egypt

Location

Related Publications (34)

• Grunwald L, Schmidutz F, Dottger P, Erne F, Schreiner AJ, Hemmann P. Leukocyte esterase and alpha-defensin in periprosthetic joint infection: predictive quality and correlation in a prospective study. Int Orthop. 2023 Nov;47(11):2663-2668. doi: 10.1007/s00264-023-05914-7. Epub 2023 Aug 16.

  PMID: 37582980 BACKGROUND

• Kheir MM, Ackerman CT, Tan TL, Benazzo A, Tischler EH, Parvizi J. Leukocyte Esterase Strip Test Can Predict Subsequent Failure Following Reimplantation in Patients With Periprosthetic Joint Infection. J Arthroplasty. 2017 Jun;32(6):1976-1979. doi: 10.1016/j.arth.2017.01.031. Epub 2017 Jan 26.

  PMID: 28215967 BACKGROUND

• Deirmengian C, Toler K, Sharma V, Miamidian JL, McLaren A. The False-Positive Rate of Synovial Fluid Culture at a Single Clinical Laboratory Using Culture Bottles. Cureus. 2024 Mar 6;16(3):e55641. doi: 10.7759/cureus.55641. eCollection 2024 Mar.

  PMID: 38586694 BACKGROUND

• Koh IJ, Han SB, In Y, Oh KJ, Lee DH, Kim TK; Knee Multicenter Collaboration Team. The Leukocyte Esterase Strip Test has Practical Value for Diagnosing Periprosthetic Joint Infection After Total Knee Arthroplasty: A Multicenter Study. J Arthroplasty. 2017 Nov;32(11):3519-3523. doi: 10.1016/j.arth.2017.06.008. Epub 2017 Jun 12.

  PMID: 28823593 BACKGROUND

• Colvin OC, Kransdorf MJ, Roberts CC, Chivers FS, Lorans R, Beauchamp CP, Schwartz AJ. Leukocyte esterase analysis in the diagnosis of joint infection: can we make a diagnosis using a simple urine dipstick? Skeletal Radiol. 2015 May;44(5):673-7. doi: 10.1007/s00256-015-2097-5. Epub 2015 Jan 29.

  PMID: 25626524 BACKGROUND

• Wetters NG, Berend KR, Lombardi AV, Morris MJ, Tucker TL, Della Valle CJ. Leukocyte esterase reagent strips for the rapid diagnosis of periprosthetic joint infection. J Arthroplasty. 2012 Sep;27(8 Suppl):8-11. doi: 10.1016/j.arth.2012.03.037. Epub 2012 May 17.

  PMID: 22608686 BACKGROUND

• Logoluso N, Pellegrini A, Suardi V, Morelli I, Battaglia AG, D'Anchise R, De Vecchi E, Zagra L. Can the Leukocyte Esterase Strip Test Predict Persistence of Periprosthetic Joint Infection at Second-Stage Reimplantation? J Arthroplasty. 2022 Mar;37(3):565-573. doi: 10.1016/j.arth.2021.11.022. Epub 2021 Nov 22.

  PMID: 34822929 BACKGROUND

• Aggarwal VK, Tischler E, Ghanem E, Parvizi J. Leukocyte esterase from synovial fluid aspirate: a technical note. J Arthroplasty. 2013 Jan;28(1):193-5. doi: 10.1016/j.arth.2012.06.023. Epub 2012 Aug 3.

  PMID: 22868070 BACKGROUND

• Uvodich ME, Dugdale EM, Osmon DR, Pagnano MW, Berry DJ, Abdel MP. The effectiveness of laboratory tests to predict early postoperative periprosthetic infection after total knee arthroplasty. Bone Joint J. 2021 Jun;103-B(6 Supple A):177-184. doi: 10.1302/0301-620X.103B6.BJJ-2020-2397.R1.

  PMID: 34053291 BACKGROUND

• 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.

  PMID: 33436902 BACKGROUND

• 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.

  PMID: 25658716 BACKGROUND

• 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.

  PMID: 20179760 BACKGROUND

• 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.

  PMID: 33109144 BACKGROUND

• 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.

  PMID: 24586496 BACKGROUND

• 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.

  PMID: 31526698 BACKGROUND

• 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.

  PMID: 25117573 BACKGROUND

• 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.

  PMID: 31759801 BACKGROUND

• Xiong L, Li S, Dai M. Comparison of D-dimer with CRP and ESR for diagnosis of periprosthetic joint infection. J Orthop Surg Res. 2019 Jul 29;14(1):240. doi: 10.1186/s13018-019-1282-y.

  PMID: 31358018 BACKGROUND

• Greidanus NV, Masri BA, Garbuz DS, Wilson SD, McAlinden MG, Xu M, Duncan CP. Use of erythrocyte sedimentation rate and C-reactive protein level to diagnose infection before revision total knee arthroplasty. A prospective evaluation. J Bone Joint Surg Am. 2007 Jul;89(7):1409-16. doi: 10.2106/JBJS.D.02602.

  PMID: 17606776 BACKGROUND

• Fu J, Ni M, Chai W, Li X, Hao L, Chen J. Synovial Fluid Viscosity Test is Promising for the Diagnosis of Periprosthetic Joint Infection. J Arthroplasty. 2019 Jun;34(6):1197-1200. doi: 10.1016/j.arth.2019.02.009. Epub 2019 Feb 13.

  PMID: 30837099 BACKGROUND

• 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.

  PMID: 19473865 BACKGROUND

• Schinsky MF, Della Valle CJ, Sporer SM, Paprosky WG. Perioperative testing for joint infection in patients undergoing revision total hip arthroplasty. J Bone Joint Surg Am. 2008 Sep;90(9):1869-75. doi: 10.2106/JBJS.G.01255.

  PMID: 18762646 BACKGROUND

• Bernard L, Lubbeke A, Stern R, Bru JP, Feron JM, Peyramond D, Denormandie P, Arvieux C, Chirouze C, Perronne C, Hoffmeyer P; Groupe D'Etude Sur L'Osteite. Value of preoperative investigations in diagnosing prosthetic joint infection: retrospective cohort study and literature review. Scand J Infect Dis. 2004;36(6-7):410-6. doi: 10.1080/00365540410015240.

  PMID: 15307559 BACKGROUND

• Berbari EF, Osmon DR, Carr A, Hanssen AD, Baddour LM, Greene D, Kupp LI, Baughan LW, Harmsen WS, Mandrekar JN, Therneau TM, Steckelberg JM, Virk A, Wilson WR. Dental procedures as risk factors for prosthetic hip or knee infection: a hospital-based prospective case-control study. Clin Infect Dis. 2010 Jan 1;50(1):8-16. doi: 10.1086/648676.

  PMID: 19951109 BACKGROUND

• Alijanipour P, Bakhshi H, Parvizi J. Diagnosis of periprosthetic joint infection: the threshold for serological markers. Clin Orthop Relat Res. 2013 Oct;471(10):3186-95. doi: 10.1007/s11999-013-3070-z.

  PMID: 23690154 BACKGROUND

• Altsitzioglou P, Avgerinos K, Karampikas V, Gavriil P, Vlachos A, Soucacou F, Zafiris I, Kontogeorgakos V, Papagelopoulos PJ, Mavrogenis AF. Point of care testing for the diagnosis of periprosthetic joint infections: a review. SICOT J. 2024;10:24. doi: 10.1051/sicotj/2024019. Epub 2024 Jun 7.

  PMID: 38847648 BACKGROUND

• 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.

  PMID: 25290132 BACKGROUND

• Schwarz EM, Parvizi J, Gehrke T, Aiyer A, Battenberg A, Brown SA, Callaghan JJ, Citak M, Egol K, Garrigues GE, Ghert M, Goswami K, Green A, Hammound S, Kates SL, McLaren AC, Mont MA, Namdari S, Obremskey WT, O'Toole R, Raikin S, Restrepo C, Ricciardi B, Saeed K, Sanchez-Sotelo J, Shohat N, Tan T, Thirukumaran CP, Winters B. 2018 International Consensus Meeting on Musculoskeletal Infection: Research Priorities from the General Assembly Questions. J Orthop Res. 2019 May;37(5):997-1006. doi: 10.1002/jor.24293. Epub 2019 Apr 25.

  PMID: 30977537 BACKGROUND

• Gazendam A, Wood TJ, Tushinski D, Bali K. Diagnosing Periprosthetic Joint Infection: a Scoping Review. Curr Rev Musculoskelet Med. 2022 Jun;15(3):219-229. doi: 10.1007/s12178-022-09751-w. Epub 2022 Apr 4.

  PMID: 35368214 BACKGROUND

• Grupkovic J, Ceculovic M, Dabetic U, Aleksandric D, Bogosavljevic N, Lazovic R, Zagorac S. Infection in Joint Arthroplasty: Diagnosis, Prevention, and Treatment Strategies-A Comprehensive Narrative Review. Life (Basel). 2025 Dec 2;15(12):1853. doi: 10.3390/life15121853.

  PMID: 41465792 BACKGROUND

• Tande AJ, Patel R. Prosthetic joint infection. Clin Microbiol Rev. 2014 Apr;27(2):302-45. doi: 10.1128/CMR.00111-13.

  PMID: 24696437 BACKGROUND

• Parvizi J, Jacovides C, Antoci V, Ghanem E. Diagnosis of periprosthetic joint infection: the utility of a simple yet unappreciated enzyme. J Bone Joint Surg Am. 2011 Dec 21;93(24):2242-8. doi: 10.2106/JBJS.J.01413.

  PMID: 22258769 BACKGROUND

• Connors JP, Stelzer JW, Garvin PM, Wellington IJ, Solovyova O. The Role of the Innate Immune System in Wear Debris-Induced Inflammatory Peri-Implant Osteolysis in Total Joint Arthroplasty. Bioengineering (Basel). 2022 Dec 4;9(12):764. doi: 10.3390/bioengineering9120764.

  PMID: 36550970 BACKGROUND

• Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.

  PMID: 17403800 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 22, 2026
• Study Start: December 21, 2022
• Primary Completion: January 5, 2024
• Study Completion: May 5, 2024
• Last Updated: July 22, 2026

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)