Knee OsteoarthritisNCT07706569
Serum Fetuin-A and COMP Levels in Knee Osteoarthritis
An observational study of Knee Osteoarthritis and Osteoarthritis, Knee, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to investigate the relationship between the clinical and radiographic severity of knee osteoarthritis (OA) and the serum levels of specific biomarkers, namely Fetuin-A and Cartilage Oligomeric Matrix Protein (COMP). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis, Osteoarthritis, Knee
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population consisted of two main groups: a patient group and a healthy control group. The patient group included individuals who presented to the Physical Medicine and Rehabilitation Outpatient Clinics of SBÜ Antalya Training and Research Hospital and were diagnosed with primary knee osteoarthritis (Stage 2-4 according to the Kellgren-Lawrence classification system). The control group consisted of healthy volunteers of similar age and gender who did not have a known joint disorder, a history of knee pain, or a systemic inflammatory disease. All participants were selected using a single-center, hospital-based convenience sampling method during the specified study period.
Who may be able to join
- Diagnosis of knee osteoarthritis according to ACR (American College of Rheumatology) criteria. Knee osteoarthritis classified as Grade 2, 3, or 4 according to Kellgren-Lawrence (K-L) grading. Volunteering to participate and providing signed informed consent.
Who cannot join
- Secondary post-traumatic knee osteoarthritis, history of major knee injury or joint infection. Signs of acute joint inflammation (swelling, heat increase, erythema). History of knee surgery (open or arthroscopic). Systemic inflammatory or autoimmune diseases. History of malignancy. Advanced renal or hepatic disease. Diagnosis of Diabetes Mellitus. Current use of systemic corticosteroids. Symptomatic osteoarthritis in other major joints (hip, hand, ankle, spine). Active systemic infection (fever ≥ 38, cough, diarrhea, dysuria, leukocytosis, or elevated CRP).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Meral Bilgilisoy Filiz, Assoc. Prof. contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
S.B.U. Antalya Training and Research Hospital, Department of Physical Medicine and Rehabilitation
Antalya
Meral Bilgilisoy Filiz, Assoc. Prof., +905056475840, mbilgilisoy@gmail.com
Burak Karaman, MD, +905079130762, burak2498@gmail.com
About this study
Official title: The Relationship Between Clinical and Radiographic Severity of Knee Osteoarthritis and Serum Fetuin-A and COMP Levels: A Controlled Cross-Sectional Study
The purpose of this study is to investigate the relationship between the clinical and radiographic severity of knee osteoarthritis (OA) and the serum levels of specific biomarkers, namely Fetuin-A and Cartilage Oligomeric Matrix Protein (COMP). Osteoarthritis is a degenerative joint disease characterized by cartilage breakdown and low-grade inflammation. Investigating these biomarkers may help healthcare providers better understand the disease pathology, potentially leading to earlier diagnosis and improved tracking of disease progression. The study will compare two distinct groups: a patient group consisting of 120 individuals diagnosed with Grade 2-4 knee osteoarthritis, and a control group of 60 age- and sex-matched healthy volunteers with no history of joint disorders. Participants will undergo radiographic evaluations using the Kellgren-Lawrence classification system, alongside clinical and functional assessments, including pain severity scales, mobility metrics, and functional questionnaires. Fasting blood samples will be collected from all participants to measure serum Fetuin-A and COMP levels via laboratory analysis, and the Systemic Inflammation Response Index (SIRI) will be calculated. The collected data will be statistically analyzed to determine if biomarker levels significantly correlate with the severity of knee joint degeneration and functional impairment.
- Conditions
- Knee Osteoarthritis, Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Knee, Fetuin-A, Cartilage Oligomeric Matrix Protein, Biological Biomarkers, Systemic Inflammation Response Index, Cross-Sectional Studies
- Medical subject headings
- Osteoarthritis, Knee, Pseudoachondroplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Knee Osteoarthritis Group | 120 patients diagnosed with primary knee osteoarthritis (Grade 2-4 according to Kellgren-Lawrence classification, 40 patients from each grade). | |
| Healthy Control Group | 60 age- and sex-matched healthy volunteers without any knee pain, history of joint disease, or systemic inflammatory conditions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Fetuin-A Levels
Measurement of serum Fetuin-A concentration using a human-specific ELISA kit to evaluate its relationship with radiographic and clinical severity.
Measured: Baseline (At the time of enrollment / single time point measurement)
Secondary outcomes (7)
Serum COMP (Cartilage Oligomeric Matrix Protein) Levels
Measured: Baseline
Radiographic Severity via Kellgren-Lawrence (K-L) Classification
Measured: Baseline
Clinical Severity and Functional Status via WOMAC Index
Measured: Baseline
Systemic Inflammation Response Index (SIRI)
(Neutrophil x Monocyte) / Lymphocyte
Measured: Baseline
Pain Severity via Visual Analog Scale (VAS)
Measured: Baseline
Functional Mobility via 10-Meter Walk Test (10MWT)
Measured: Baseline
Lower Extremity Muscle Strength via 5-Times Sit-to-Stand Test (5x STS)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Apr 2026
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Collaborators
- Saglik Bilimleri Universitesi
- Responsible party
- Principal investigator, Burak Karaman, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706569
- Sponsor's protocol ID
- 2026-108
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Clinical and Radiographic Severity of Knee Osteoarthritis and Serum Fetuin-A and COMP Levels: A Controlled Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07706569
- Acronym / sponsor ID
- 2026-108
- Conditions
- Knee Osteoarthritis, Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Knee, Fetuin-A, Cartilage Oligomeric Matrix Protein, Biological Biomarkers, Systemic Inflammation Response Index, Cross-Sectional Studies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Collaborators
- Saglik Bilimleri Universitesi
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 15 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.
The purpose of this study is to investigate the relationship between the clinical and radiographic severity of knee osteoarthritis (OA) and the serum levels of specific biomarkers, namely Fetuin-A and Cartilage Oligomeric Matrix Protein (COMP). Osteoarthritis is a degenerative joint disease characterized by cartilage breakdown and low-grade inflammation. Investigating these biomarkers may help healthcare providers better understand the disease pathology, potentially leading to earlier diagnosis and improved tracking of disease progression. The study will compare two distinct groups: a patient group consisting of 120 individuals diagnosed with Grade 2-4 knee osteoarthritis, and a control group of 60 age- and sex-matched healthy volunteers with no history of joint disorders. Participants will undergo radiographic evaluations using the Kellgren-Lawrence classification system, alongside clinical and functional assessments, including pain severity scales, mobility metrics, and functional questionnaires. Fasting blood samples will be collected from all participants to measure serum Fetuin-A and COMP levels via laboratory analysis, and the Systemic Inflammation Response Index (SIRI) will be calculated. The collected data will be statistically analyzed to determine if biomarker levels significantly correlate with the severity of knee joint degeneration and functional impairment.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Knee Osteoarthritis Group | – | –120 patients diagnosed with primary knee osteoarthritis (Grade 2-4 according to Kellgren-Lawrence classification, 40 patients from each grade). |
| Healthy Control Group | – | –60 age- and sex-matched healthy volunteers without any knee pain, history of joint disease, or systemic inflammatory conditions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consisted of two main groups: a patient group and a healthy control group. The patient group included individuals who presented to the Physical Medicine and Rehabilitation Outpatient Clinics of SBÜ Antalya Training and Research Hospital and were diagnosed with primary knee osteoarthritis (Stage 2-4 according to the Kellgren-Lawrence classification system). The control group consisted of healthy volunteers of similar age and gender who did not have a known joint disorder, a history of knee pain, or a systemic inflammatory disease. All participants were selected using a single-center, hospital-based convenience sampling method during the specified study period.
Key inclusion criteria (1 listed)
- Diagnosis of knee osteoarthritis according to ACR (American College of Rheumatology) criteria. Knee osteoarthritis classified as Grade 2, 3, or 4 according to Kellgren-Lawrence (K-L) grading. Volunteering to participate and providing signed informed consent.
Key exclusion criteria (1 listed)
- Secondary post-traumatic knee osteoarthritis, history of major knee injury or joint infection. Signs of acute joint inflammation (swelling, heat increase, erythema). History of knee surgery (open or arthroscopic). Systemic inflammatory or autoimmune diseases. History of malignancy. Advanced renal or hepatic disease. Diagnosis of Diabetes Mellitus. Current use of systemic corticosteroids. Symptomatic osteoarthritis in other major joints (hip, hand, ankle, spine). Active systemic infection (fever ≥ 38, cough, diarrhea, dysuria, leukocytosis, or elevated CRP).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum Fetuin-A Levels
Time frame: Baseline (At the time of enrollment / single time point measurement)
Measurement of serum Fetuin-A concentration using a human-specific ELISA kit to evaluate its relationship with radiographic and clinical severity.
7 secondary outcomes
Serum COMP (Cartilage Oligomeric Matrix Protein) Levels
Time frame: Baseline
Radiographic Severity via Kellgren-Lawrence (K-L) Classification
Time frame: Baseline
Clinical Severity and Functional Status via WOMAC Index
Time frame: Baseline
Systemic Inflammation Response Index (SIRI)
Time frame: Baseline
Pain Severity via Visual Analog Scale (VAS)
Time frame: Baseline
Functional Mobility via 10-Meter Walk Test (10MWT)
Time frame: Baseline
Lower Extremity Muscle Strength via 5-Times Sit-to-Stand Test (5x STS)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
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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.
Meral Bilgilisoy Filiz, Assoc. Prof. contact
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 Knee Osteoarthritis and Osteoarthritis, Knee, run by Antalya Training and Research Hospital 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 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: looking for participants now, as of the sponsor's last update on 15 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Burak Karaman, MD (+905079130762, burak2498@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Fetuin-A Levels (time frame: Baseline (At the time of enrollment / single time point measurement)). 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 15 Jul 2026.