Clinical trial NCT04796129: Correlation of the Inflammatory Parameters With Pain and Radiological Findings in Coxarthrosis
Official title: Evaluation of the Correlation of the Inflammatory Parameters With Pain and Radiological Findings in Patients With Coxarthrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Hip
Inflammation
Pain
Keywords: hip osteoarthritis
inflammation
pain severity
pain level
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: Kanuni Sultan Suleyman Training and Research Hospital
name: Abant Izzet Baysal University
First posted: 2021-03-12
Enrollment: 135
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 1 day
measure: NLR
timeFrame: 1day
measure: PLR
timeFrame: 1 day
measure: MLR
timeFrame: 1 day
measure: ESR
timeFrame: 1 day
measure: CRP
timeFrame: 1 day
measure: X-ray of hip joints
timeFrame: 1 day
measure: Lequesne Index
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Suleyman Training and Research Hospital
Study officials:
affiliation: Istanbul University
name: Merve Damla Korkmaz, 1
role: PRINCIPAL_INVESTIGATOR
References: