Periprosthetic Joint Infection (PJI)ESR/CRP/LE pjiNCT07718386
Efficacy of Serum ESR, CRP, Synovial Leucocyte Esterase Dipstick Test in The Diagnosis of Chronic Infection in Total Joint Arthroplasty
A study testing CRP, ESR and Leukocyte esterase dipstick test in people with Periprosthetic Joint Infection (PJI), run by Ain Shams University at 1 site in Egypt.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periprosthetic Joint Infection (PJI)
- What is being tested?
- CRP, ESR and Leukocyte esterase dipstick test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Dec 2022to 5 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Infected and query infected TJR patients Time of presentation >=4 weeks post op.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
Read the 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.
- Conditions
- Periprosthetic Joint Infection (PJI)
- Being tested
- CRP, ESR, Leukocyte esterase dipstick test
- Keywords
- PJI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRPDiagnostic test
serum level of CRP is measured
ESRDiagnostic test
ESR serum levels are measured
Leukocyte esterase dipstick testDiagnostic test
LE box within the urinary dipstick test is measured
| Study group | Role | What they receive |
|---|---|---|
| Active / sample arm | Experimental | patients with pji Receives: Diagnostic Test: CRP; Diagnostic Test: ESR; Diagnostic Test: Leukocyte esterase dipstick test |
| control group | Active comparator | control arm Receives: Diagnostic Test: CRP; Diagnostic Test: ESR; Diagnostic Test: Leukocyte esterase dipstick test |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum ESR level
(mm/hr)(more than or equal 30mm/hr is considered positive/infected{PJI})
Measured: at day 0
serum CRP level
(mg/L)(more than or equal 10 mg/L is considered positive/infected{PJI})
Measured: at day 0
Synovial Leukocyte esterase dipstick test
(Plus 1 or more is considered positive/infected{PJI})
Measured: at day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start21 Dec 2022
- Primary completion5 Jan 2024
- Study completion5 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Periprosthetic Joint Infection (PJI)Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718386
- Sponsor's protocol ID
- FMASU MD323/2022
- Acronym
- ESR/CRP/LE pji
- Status last verified
- Dec 2022
- First submitted
- 29 Jun 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37582980Kheir 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.
PubMed 28215967Deirmengian 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.
PubMed 38586694Koh 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.
PubMed 28823593Colvin 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.
PubMed 25626524Wetters 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.
PubMed 22608686Logoluso 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.
PubMed 34822929Aggarwal 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.
PubMed 22868070Uvodich 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.
PubMed 34053291Yang 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.
PubMed 33436902Yuan 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.
PubMed 25658716Piper 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.
PubMed 20179760Yu 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.
PubMed 33109144Randau 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.
PubMed 24586496Qin 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.
PubMed 31526698
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnosis Dilemma: Efficacy of Serum ESR, CRP, Synovial Leucocyte Esterase Dipstick Test in the Diagnosis of Chronic Infection in Total Joint Arthroplasty.
- ClinicalTrials.gov ID
- NCT07718386
- Acronym / sponsor ID
- ESR/CRP/LE pji / FMASU MD323/2022
- Conditions
- Periprosthetic Joint Infection (PJI)
- Keywords
- PJI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 5 May 2024 (actual)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active / sample arm | Experimental | Diagnostic Test: CRP, Diagnostic Test: ESR, Diagnostic Test: Leukocyte esterase dipstick testpatients with pji |
| control group | Active comparator | Diagnostic Test: CRP, Diagnostic Test: ESR, Diagnostic Test: Leukocyte esterase dipstick testcontrol arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Infected and query infected TJR patients Time of presentation >=4 weeks post op.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRPserum level of CRP is measured | Diagnostic test | Active / sample arm, control group |
| ESRESR serum levels are measured | Diagnostic test | Active / sample arm, control group |
| Leukocyte esterase dipstick testLE box within the urinary dipstick test is measured | Diagnostic test | Active / sample arm, control group |
Primary outcome
serum ESR level
Time frame: at day 0
(mm/hr)(more than or equal 30mm/hr is considered positive/infected{PJI})
serum CRP level
Time frame: at day 0
(mg/L)(more than or equal 10 mg/L is considered positive/infected{PJI})
Synovial Leukocyte esterase dipstick test
Time frame: at day 0
(Plus 1 or more is considered positive/infected{PJI})
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Background: PubMed 37582980Grunwald 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.
- Background: PubMed 28215967Kheir 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.
- Background: PubMed 38586694Deirmengian 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.
- Background: PubMed 28823593Koh 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.
- Background: PubMed 25626524Colvin 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.
- Background: PubMed 22608686Wetters 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.
- Background: PubMed 34822929Logoluso 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.
- Background: PubMed 22868070Aggarwal 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.
- Background: PubMed 34053291Uvodich 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.
- Background: PubMed 33436902Yang 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.
- Background: PubMed 25658716Yuan 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.
- Background: PubMed 20179760Piper 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRP, ESR and Leukocyte esterase dipstick test in people with Periprosthetic Joint Infection (PJI), run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum ESR level (time frame: at day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07718386, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.