Correlation of the Inflammatory Parameters With Pain and Radiological Findings in Coxarthrosis

February 17, 2022 updated by: Merve Damla Korkmaz, Istanbul University

Evaluation of the Correlation of the Inflammatory Parameters With Pain and Radiological Findings in Patients With Coxarthrosis

Osteoarthritis (OA) is a functional disease with joint degeneration with subchondral and periosteal lesions. Coxarthrosis (or hip osteoarthritis) is an important cause of disability, especially in the advanced age group.Although hip osteoarthritis is often thought to be a non-inflammatory pathology, recent studies have shown that joint degeneration is correlated with the production of inflammatory factors and cartilage destroying enzymes.

There are very few studies evaluating the correlation of Neutrophil lymphocyte ratio, monocyte lymphocyte ratio and Platelet lymphocyte ratio with inflammatory parameters CRP and ESR levels in hip osteoarthritis and its relation with the staging of hip osteoatritis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Osteoarthritis (OA) is a disease characterized by joint degeneration with subchondral and periosteal lesions . Coxarthrosis (hip osteoarthritis) is an important cause of disability, especially in the advanced age group. The risk of symptomatic coxarthrosis in persons up to the age of 85 is approximately 25%. There is a possibility of total hip replacement at a rate of approximately 10% due to advanced stage coxarthrosis. Kellgren-Lawrence staging system is used to show disease severity in osteoarthritis staging. According to this, Stage 0: there is no radiological change, Stage 1: there is a slight narrowing in the joint space, Stage 2: osteophytes are formed in the joint space with stenosis in the anteroposterior radiography, Stage 3: multiple osteophytes, significant narrowing of the joint space, sclerosis and Stage 4 It describes a situation accompanied by large osteophytes, severe stenosis in the joint space, prominent sclerosis, and bone deformities.

Although coxarthrosis is often thought to be a non-inflammatory pathology, recent studies have shown that joint degeneration correlates with the production of inflammatory factors and cartilage destroying enzymes. At the cellular level, it has been found that macrophage and perivascular T and B lymphocyte infiltration play a role in early and advanced stage OA.

Neutrophils and lymphocytes are the main determinants of the inflammatory process. The neutrophil to lymphocyte ratio (NLR) is obtained by dividing the absolute neutrophil count by the number of lymphocytes obtained from the peripheral blood count. They are used as an indicator of the inflammatory process in inflammatory conditions such as ankylosing spondylitis, sarcoidosis, and cancers. In addition, platelet lymphocyte ratio (PLR) has also been found to be associated with disease activity and severity in diseases such as rheumatoid arthritis and psoriatic arthritis. Its use in the diagnosis and follow-up of OA has not yet been clearly demonstrated. However, changes in mean platelet volume are also used as an indicator of disease severity in systemic inflammatory diseases.

There are very few studies evaluating the correlation of Neutrophil lymphocyte ratio, monocyte lymphocyte ratio and Platelet lymphocyte ratio with inflammatory parameters CRP and ESR levels in hip osteoarthritis and its relation with the staging of hip osteoatritis. The aim of this study to evaluate of the correlation of the inflammatory parameters with pain and radiological findings in the patients with coxarthrosis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
135

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34303
        • Kanuni Sultan Suleyman Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

the participants in the experimental group are at aged 45 years or older and have hip osteoarthritis the participants in the control group are at aged 45 years or older and have no any other diseases that effect the inflammatory status

Description

Inclusion Criteria:

  • Being diagnosed with hip osteoarthritis
  • Being aged at 45 years or older

Exclusion Criteria:

  • Not accept being participation in the study.
  • Having any systemic disease like the diabetes mellitus, hypertension, coronary after disease
  • Having any inflammatory rheumatologic disease
  • Having any disease that prevent to participate the study like mental retardation, dementia and psychotic disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
patients with hip osteoarthritis
the patients who aged 45 and older and have paint in the hips. and also without having any other comorbidities about inflammatory status.
Other: the patients with hip osteoarthritis and their inflammatory status
The participants in the experimental group will be evaluated for the hip osteoarthritis. They will take and X-ray for hip joints and also hemogram for the excluding the inflammatory diseases.
control
the participants who have any other comorbidities for impact on the inflammatory status and also no hip pain.
Other: the patients with hip osteoarthritis and their inflammatory status
The participants in the experimental group will be evaluated for the hip osteoarthritis. They will take and X-ray for hip joints and also hemogram for the excluding the inflammatory diseases.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: 1 day
pain of the hip joints of the participants. It will be evaluated by using Visual Analog Scale(VAS). The scale is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations. The pain range is from 1 to 10. The minimum value is 1 and it means the pain is so mild. The maximum value is 10, it means the pain is so much, like a knife stabs.
1 day
NLR
Time Frame: 1day
neutrophil lymphocyte ratio
1day
PLR
Time Frame: 1 day
platelet lymphocyte ratio
1 day
MLR
Time Frame: 1 day
monocyte lymphocyte ratio
1 day
ESR
Time Frame: 1 day
Erythrocyte Sedimentation Ratio
1 day
CRP
Time Frame: 1 day
C-reactive protein
1 day
X-ray of hip joints
Time Frame: 1 day
an AP X-ray for the painful hip joints
1 day
Lequesne Index
Time Frame: 1 day
pain severity
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Kanuni Sultan Suleyman Training and Research Hospital
Abant Izzet Baysal University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Merve Damla Korkmaz, 1, Istanbul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 11, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 10, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 10, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020/329

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

all IPD that underlie results in a publication)

IPD Sharing Time Frame

The data will be available after publication

IPD Sharing Access Criteria

The data will share with permission and request.

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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