Osteoarthritis, HipNCT04796129
Correlation of the Inflammatory Parameters With Pain and Radiological Findings in Coxarthrosis
An observational study of Osteoarthritis, Hip and Inflammation, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Hip, Inflammation, Pain
- What is being tested?
- the patients with hip osteoarthritis and their inflammatory status
- How many people
- 135 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Feb 2021to 10 Jan 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Being diagnosed with hip osteoarthritis
- Being aged at 45 years or older
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, 34303
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis, Hip, Inflammation, Pain
- Being tested
- the patients with hip osteoarthritis and their inflammatory status
- Keywords
- hip osteoarthritis, inflammation, pain severity, pain level
- Medical subject headings
- Osteoarthritis, Hip, Inflammation, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the patients with hip osteoarthritis and their inflammatory statusOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: the patients with hip osteoarthritis and their inflammatory status | |
| control | the participants who have any other comorbidities for impact on the inflammatory status and also no hip pain. Receives: Other: the patients with hip osteoarthritis and their inflammatory status |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
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.
Measured: 1 day
NLR
neutrophil lymphocyte ratio
Measured: 1day
PLR
platelet lymphocyte ratio
Measured: 1 day
MLR
monocyte lymphocyte ratio
Measured: 1 day
ESR
Erythrocyte Sedimentation Ratio
Measured: 1 day
CRP
C-reactive protein
Measured: 1 day
X-ray of hip joints
an AP X-ray for the painful hip joints
Measured: 1 day
Lequesne Index
pain severity
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start11 Feb 2021
- Primary completion10 Nov 2021
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Kanuni Sultan Suleyman Training and Research Hospital, Abant Izzet Baysal University
- Responsible party
- Principal investigator, Merve Damla Korkmaz, Istanbul University
- Investigators
- Merve Damla Korkmaz, 1, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796129
- Sponsor's protocol ID
- 2020/329
- Status last verified
- Feb 2022
- First submitted
- 10 Feb 2021
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication)
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Correlation of the Inflammatory Parameters With Pain and Radiological Findings in Patients With Coxarthrosis
- ClinicalTrials.gov ID
- NCT04796129
- Acronym / sponsor ID
- 2020/329
- Conditions
- Osteoarthritis, Hip, Inflammation, Pain
- Keywords
- hip osteoarthritis, inflammation, pain severity, pain level
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Kanuni Sultan Suleyman Training and Research Hospital, Abant Izzet Baysal University
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 10 Nov 2021 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 12 Mar 2021 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with hip osteoarthritis | – | Other: the patients with hip osteoarthritis and their inflammatory statusthe patients who aged 45 and older and have paint in the hips. and also without having any other comorbidities about inflammatory status. |
| control | – | Other: the patients with hip osteoarthritis and their inflammatory statusthe participants who have any other comorbidities for impact on the inflammatory status and also no hip pain. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Being diagnosed with hip osteoarthritis
- Being aged at 45 years or older
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| the patients with hip osteoarthritis and their inflammatory statusThe 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. | Other | control, patients with hip osteoarthritis |
Primary outcome
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.
NLR
Time frame: 1day
neutrophil lymphocyte ratio
PLR
Time frame: 1 day
platelet lymphocyte ratio
MLR
Time frame: 1 day
monocyte lymphocyte ratio
ESR
Time frame: 1 day
Erythrocyte Sedimentation Ratio
CRP
Time frame: 1 day
C-reactive protein
X-ray of hip joints
Time frame: 1 day
an AP X-ray for the painful hip joints
Lequesne Index
Time frame: 1 day
pain severity
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 21 Feb 2022.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication)
Related trials for Osteoarthritis, Hip
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Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
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.
Merve Damla Korkmaz, 1 principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Hip and Inflammation, run by Istanbul University at 1 site in Turkey (Türkiye).
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 2 inclusion and 4 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 21 Feb 2022. 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 Turkey (Türkiye). 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?
Visual Analog Scale (time frame: 1 day). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2022.