- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06432530
Can Hematological Inflammatory Indexes be Used to Differentiate Type 1 Modic Changes From Brucella Spondylodiscitis
Study Overview
Status
Conditions
Detailed Description
This is a retrospective comparative study focusing to distinguish between brucella spondylodiscitis and type 1 MCs considering hematological inflammatory indexes. Patients' data were obtained from Hospital Information Systems, between 2020 to 2024. A total of 35 patients with brucella spondylodiscitis and 37 type 1 MCs were enrolled in the study. Diagnoses of brucella spondylodiscitis and type 1 MCs were supported by microbiological, serological, and radiological diagnostic tools. Patients' hematological parameters were recorded, and hematological inflammatory indexes (NLR, MLR, PLR, NLPR, SII, SIRI, AISI) were derived from baseline CBC tests.
Based on the diagnostic tools and criteria1,2,14,21, cases diagnosed with lumbar brucella spondylodiscitis or lumbar type 1 MCs in the past 5 years and who had simultaneously lumbar MRI, Complete Blood Count (CBC) test, C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR) results, and aged 18-65 years were selected to yield a study population. On the other hand, cases with inadequate data, aged <18 or >64 years, other infectious spondylodiscitis types than brucella, other MCs types than type 1, and other non-infectious conditions such as rheumatic spondylodiscitis (ankylosing spondylitis or Andersson lesion) were excluded from the study. Also, previous or recurrent brucella spondylodiscitis, involved other spinal levels than the lumbar spine were exclusion causes.
The two groups were statistically assessed and compared for baseline features such as age, gender, symptom duration, CRP, ESR, CBC values, and indexes derived from the CBC.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Van, Turkey, 65040
- Volkan Şah
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Clinical diagnosis of lumbar brucella spondylodiscitis in the past 5 years
- Clinical diagnosis of or lumbar type 1 Modic Changes (MCs) in the past 5 years
- Having simultaneously lumbar Magnetic Resonance Imaging (MRI), Complete Blood Count (CBC) test, C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR) results
- Being between the ages of 18-65
Exclusion Criteria:
- Cases with inadequate data
- Being under 18 years of age and over 65 years of age
- Having other infectious spondylodiscitis types than brucella
- Having other MCs types than type 1
- Having other non-infectious conditions such as rheumatic spondylodiscitis (ankylosing spondylitis or Andersson lesion)
- Having previous or recurrent brucella spondylodiscitis, involved other spinal levels than the lumbar spine
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
37 patients with type 1 Modic Changes (MCs)
Diagnoses of brucella spondylodiscitis and type 1 MCs were supported by microbiological, serological, and radiological diagnostic tools.
Based on the diagnostic tools and criteria, cases diagnosed with lumbar brucella spondylodiscitis or lumbar type 1 MCs in the past 5 years and who had simultaneously lumbar Magnetic Resonance Imaging (MRI), Complete Blood Count (CBC) test, C-reactive protein (CRP), and Erythrocyte Sedimentation Rate (ESR) results, and aged 18-65 years were selected to yield a study population
|
Patients' hematological parameters were recorded, and hematological inflammatory indexes (NLR: neutrophil/lymphocyte; MLR: monocyte/lymphocyte; PLR: platelet/lymphocyte; NLPR: neutrophil/(lymphocyte*platelet); SII (neutrophil*platelet/lymphocyte): systemic inflammatory index; SIRI (neutrophil*monocyte/lymphocyte): systemic inflammatory response index; AISI (neutrophil*platelet*monocyte/lymphocyte): aggregate index of systemic inflammation.
) were derived from baseline CBC tests.
|
|
35 patients with brucella spondylodiscitis
Diagnoses of brucella spondylodiscitis and type 1 MCs were supported by microbiological, serological, and radiological diagnostic tools.
Based on the diagnostic tools and criteria, cases diagnosed with lumbar brucella spondylodiscitis or lumbar type 1 MCs in the past 5 years and who had simultaneously lumbar Magnetic Resonance Imaging (MRI), Complete Blood Count (CBC) test, C-reactive protein (CRP), and Erythrocyte Sedimentation Rate (ESR) results, and aged 18-65 years were selected to yield a study population
|
Patients' hematological parameters were recorded, and hematological inflammatory indexes (NLR: neutrophil/lymphocyte; MLR: monocyte/lymphocyte; PLR: platelet/lymphocyte; NLPR: neutrophil/(lymphocyte*platelet); SII (neutrophil*platelet/lymphocyte): systemic inflammatory index; SIRI (neutrophil*monocyte/lymphocyte): systemic inflammatory response index; AISI (neutrophil*platelet*monocyte/lymphocyte): aggregate index of systemic inflammation.
) were derived from baseline CBC tests.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
C-Reactive Protein (CRP)
Time Frame: Baseline
|
As an inflammatory index.
|
Baseline
|
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Erythrocyte Sedimentation Rate (ESR)
Time Frame: Baseline
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As an inflammatory index.
|
Baseline
|
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Neutrophil/Lymphocyte Rate (NLR)
Time Frame: Baseline
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As a hematological inflammatory index
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Baseline
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Monocyte/Lymphocyte Rate (MLR)
Time Frame: Baseline
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As a hematological inflammatory index
|
Baseline
|
|
Platelet/Lymphocyte Rate (PLR)
Time Frame: Baseline
|
As a hematological inflammatory index
|
Baseline
|
|
Neutrophil/(Lymphocyte*Platelet) Rate (NLPR)
Time Frame: Baseline
|
As a hematological inflammatory index
|
Baseline
|
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(neutrophil*platelet/lymphocyte): Systemic Inflammatory Index (SII)
Time Frame: Baseline
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As a hematological inflammatory index
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Baseline
|
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(neutrophil*monocyte/lymphocyte): Systemic Inflammatory Response Index (SIRI)
Time Frame: Baseline
|
As a hematological inflammatory index
|
Baseline
|
|
(neutrophil*platelet*monocyte/lymphocyte): Aggregate Index of Systemic Inflammation (AISI)
Time Frame: Baseline
|
As a hematological inflammatory index
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ali İrfan Baran, Yüzüncü Yıl Üniversitesi Tıp Fakültesi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- University of Van Yüzüncü Yıl
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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