Knee OsteoarthritisKOACOMPNCT07528872
Serum COMP and MMP-3 in Knee Osteoarthritis
An observational study of Knee Osteoarthritis, run by Kanuni Sultan Suleyman Training and Research Hospital.
Trial summary
Knee osteoarthritis is a common degenerative joint disease characterized by pain, stiffness, and functional limitation, significantly affecting quality of life. In addition to mechanical factors, cartilage degradation and extracellular matrix remodeling play a key role in disease progression. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Observational Study
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to 1 Jun 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of adult participants aged 40-75 years recruited from the outpatient clinic of Physical Medicine and Rehabilitation. The patient group will include individuals with clinically and radiologically confirmed knee osteoarthritis, while the control group will consist of age- and sex-matched healthy volunteers without knee pain or radiographic evidence of osteoarthritis. All participants will be able to comply with study procedures and will provide written informed consent prior to enrollment.
Who may be able to join
- Age between 40 and 75 years Male and female participants For patient group: clinically and radiologically confirmed diagnosis of knee osteoarthritis Kellgren-Lawrence grade 2-3 (or 2-4 if you decide to include advanced stages) Ability to understand and comply with study procedures Willingness to participate and provision of written informed consent For control group: absence of knee pain and no radiographic evidence of knee osteoarthritis
Who cannot join
- Presence of inflammatory rheumatic diseases (e.g., rheumatoid arthritis, ankylosing spondylitis) History of acute knee trauma Previous knee surgery (e.g., arthroplasty or arthroscopy) History of septic arthritis or active infection History of malignancy Severe systemic diseases (e.g., advanced cardiac, renal, or hepatic failure) Neuromuscular disorders affecting lower extremity function Intra-articular injection (e.g., corticosteroids, PRP) within the last 3 months Other conditions that may cause knee pain apart from osteoarthritis Cognitive or psychiatric conditions preventing compliance with study procedures Refusal to provide informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Relationship Between Serum COMP (Cartilage Oligomeric Matrix Protein) and MMP-3 (Matrix Metalloproteinase-3) Levels and Clinical and Radiological Severity in Patients With Knee Osteoarthritis
Knee osteoarthritis is a common degenerative joint disease characterized by pain, stiffness, and functional limitation, significantly affecting quality of life. In addition to mechanical factors, cartilage degradation and extracellular matrix remodeling play a key role in disease progression. Therefore, identifying reliable biomarkers reflecting disease severity has become an important research focus.
Cartilage oligomeric matrix protein (COMP) is a structural component of cartilage associated with cartilage turnover, while matrix metalloproteinase-3 (MMP-3) is a proteolytic enzyme involved in extracellular matrix degradation. Both biomarkers have been suggested to be elevated in osteoarthritis and may reflect disease severity.
Read more
The aim of this cross-sectional observational study is to evaluate the relationship between serum COMP and MMP-3 levels and clinical and radiological severity in patients with knee osteoarthritis. Pain severity will be assessed using the Visual Analog Scale (VAS), functional status with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and radiological severity with the Kellgren-Lawrence classification. Functional performance will also be evaluated using the 5 Times Sit-to-Stand Test.
Additionally, serum COMP and MMP-3 levels will be compared between patients with knee osteoarthritis and healthy controls. The findings of this study are expected to contribute to a better understanding of the relationship between biochemical markers and clinical severity in osteoarthritis and may provide insight into their potential diagnostic and prognostic value.
Read the detailed description
Knee osteoarthritis (OA) is one of the most prevalent musculoskeletal disorders and a leading cause of pain, disability, and reduced quality of life worldwide. The pathophysiology of OA involves not only mechanical degeneration but also complex biological processes including cartilage degradation, synovial inflammation, and extracellular matrix remodeling. In recent years, there has been growing interest in identifying biochemical markers that can reflect disease severity and progression.
Cartilage oligomeric matrix protein (COMP) is a non-collagenous extracellular matrix protein predominantly found in cartilage, and its serum levels are considered to reflect cartilage turnover and degradation. Matrix metalloproteinase-3 (MMP-3) is an important proteolytic enzyme involved in the breakdown of extracellular matrix components and plays a key role in cartilage destruction in osteoarthritis. Elevated levels of these biomarkers have been reported in patients with OA and may be associated with disease severity.
This cross-sectional observational study is designed to investigate the relationship between serum COMP and MMP-3 levels and clinical and radiological severity in patients with knee osteoarthritis. A total of 60 participants will be included, consisting of 30 patients diagnosed with knee osteoarthritis and 30 healthy controls with similar demographic characteristics.
Clinical assessment will include pain severity measured by the Visual Analog Scale (VAS) and functional status assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Functional performance will be evaluated using the 5 Times Sit-to-Stand Test. Radiological severity will be determined according to the Kellgren-Lawrence classification based on standard knee radiographs.
Venous blood samples will be collected under aseptic conditions. Serum samples will be separated by centrifugation and stored under appropriate conditions until analysis. Serum COMP and MMP-3 levels will be measured using validated enzyme-linked immunosorbent assay (ELISA) kits in an accredited laboratory. All samples will be analyzed according to the manufacturer's instructions.
The primary objective of the study is to evaluate the association between serum COMP and MMP-3 levels and clinical and radiological severity parameters in knee osteoarthritis. Secondary objectives include comparing biomarker levels between patients and healthy controls and exploring the independent predictive value of these biomarkers after adjusting for potential confounding factors such as age, sex, and body mass index.
It is hypothesized that serum COMP and MMP-3 levels will be significantly higher in patients with knee osteoarthritis compared to healthy controls and will show a positive correlation with pain severity, functional impairment, and radiological grade. The findings of this study may contribute to a better understanding of the role of biochemical markers in osteoarthritis and support their potential use in clinical assessment and disease monitoring.
- Conditions
- Knee Osteoarthritis
- Being tested
- Observational Study
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational StudyOther
This is an observational study with no intervention. Participants will undergo clinical, radiological, and laboratory assessments, including serum biomarker analysis, without any therapeutic or experimental intervention.
| Study group | Role | What they receive |
|---|---|---|
| Knee Osteoarthritis | Patients diagnosed with knee osteoarthritis Receives: Other: Observational Study | |
| Healthy Control | Age- and sex-matched healthy individuals without knee osteoarthritis Receives: Other: Observational Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum COMP and MMP-3 Levels
Serum levels of cartilage oligomeric matrix protein (COMP) and matrix metalloproteinase-3 (MMP-3) will be measured using ELISA. The association between biomarker levels and clinical (VAS, WOMAC), functional (5 Times Sit-to-Stand Test), and radiological (Kellgren-Lawrence grade) severity parameters will be evaluated.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study startApr 2026 (estimated)
- Primary completion15 May 2026 (estimated)
- Study completion1 Jun 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Karakuzu Güngör, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07528872
- Sponsor's protocol ID
- KOA-COMP-MMP3-2026-01
- Acronym
- KOACOMP
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Serum COMP (Cartilage Oligomeric Matrix Protein) and MMP-3 (Matrix Metalloproteinase-3) Levels and Clinical and Radiological Severity in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07528872
- Acronym / sponsor ID
- KOACOMP / KOA-COMP-MMP3-2026-01
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 14 Apr 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.
Knee osteoarthritis is a common degenerative joint disease characterized by pain, stiffness, and functional limitation, significantly affecting quality of life. In addition to mechanical factors, cartilage degradation and extracellular matrix remodeling play a key role in disease progression. Therefore, identifying reliable biomarkers reflecting disease severity has become an important research focus.
Cartilage oligomeric matrix protein (COMP) is a structural component of cartilage associated with cartilage turnover, while matrix metalloproteinase-3 (MMP-3) is a proteolytic enzyme involved in extracellular matrix degradation. Both biomarkers have been suggested to be elevated in osteoarthritis and may reflect disease severity.
The aim of this cross-sectional observational study is to evaluate the relationship between serum COMP and MMP-3 levels and clinical and radiological severity in patients with knee osteoarthritis. Pain severity will be assessed using the Visual Analog Scale (VAS), functional status with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and radiological severity with the Kellgren-Lawrence classification. Functional performance will also be evaluated using the 5 Times Sit-to-Stand Test.
Additionally, serum COMP and MMP-3 levels will be compared between patients with knee osteoarthritis and healthy controls. The findings of this study are expected to contribute to a better understanding of the relationship between biochemical markers and clinical severity in osteoarthritis and may provide insight into their potential diagnostic and prognostic value.
Detailed description
Knee osteoarthritis (OA) is one of the most prevalent musculoskeletal disorders and a leading cause of pain, disability, and reduced quality of life worldwide. The pathophysiology of OA involves not only mechanical degeneration but also complex biological processes including cartilage degradation, synovial inflammation, and extracellular matrix remodeling. In recent years, there has been growing interest in identifying biochemical markers that can reflect disease severity and progression.
Cartilage oligomeric matrix protein (COMP) is a non-collagenous extracellular matrix protein predominantly found in cartilage, and its serum levels are considered to reflect cartilage turnover and degradation. Matrix metalloproteinase-3 (MMP-3) is an important proteolytic enzyme involved in the breakdown of extracellular matrix components and plays a key role in cartilage destruction in osteoarthritis. Elevated levels of these biomarkers have been reported in patients with OA and may be associated with disease severity.
This cross-sectional observational study is designed to investigate the relationship between serum COMP and MMP-3 levels and clinical and radiological severity in patients with knee osteoarthritis. A total of 60 participants will be included, consisting of 30 patients diagnosed with knee osteoarthritis and 30 healthy controls with similar demographic characteristics.
Clinical assessment will include pain severity measured by the Visual Analog Scale (VAS) and functional status assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Functional performance will be evaluated using the 5 Times Sit-to-Stand Test. Radiological severity will be determined according to the Kellgren-Lawrence classification based on standard knee radiographs.
Venous blood samples will be collected under aseptic conditions. Serum samples will be separated by centrifugation and stored under appropriate conditions until analysis. Serum COMP and MMP-3 levels will be measured using validated enzyme-linked immunosorbent assay (ELISA) kits in an accredited laboratory. All samples will be analyzed according to the manufacturer's instructions.
The primary objective of the study is to evaluate the association between serum COMP and MMP-3 levels and clinical and radiological severity parameters in knee osteoarthritis. Secondary objectives include comparing biomarker levels between patients and healthy controls and exploring the independent predictive value of these biomarkers after adjusting for potential confounding factors such as age, sex, and body mass index.
It is hypothesized that serum COMP and MMP-3 levels will be significantly higher in patients with knee osteoarthritis compared to healthy controls and will show a positive correlation with pain severity, functional impairment, and radiological grade. The findings of this study may contribute to a better understanding of the role of biochemical markers in osteoarthritis and support their potential use in clinical assessment and disease monitoring.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Knee Osteoarthritis | – | Other: Observational StudyPatients diagnosed with knee osteoarthritis |
| Healthy Control | – | Other: Observational StudyAge- and sex-matched healthy individuals without knee osteoarthritis |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult participants aged 40-75 years recruited from the outpatient clinic of Physical Medicine and Rehabilitation. The patient group will include individuals with clinically and radiologically confirmed knee osteoarthritis, while the control group will consist of age- and sex-matched healthy volunteers without knee pain or radiographic evidence of osteoarthritis. All participants will be able to comply with study procedures and will provide written informed consent prior to enrollment.
Key inclusion criteria (1 listed)
- Age between 40 and 75 years Male and female participants For patient group: clinically and radiologically confirmed diagnosis of knee osteoarthritis Kellgren-Lawrence grade 2-3 (or 2-4 if you decide to include advanced stages) Ability to understand and comply with study procedures Willingness to participate and provision of written informed consent For control group: absence of knee pain and no radiographic evidence of knee osteoarthritis
Key exclusion criteria (1 listed)
- Presence of inflammatory rheumatic diseases (e.g., rheumatoid arthritis, ankylosing spondylitis) History of acute knee trauma Previous knee surgery (e.g., arthroplasty or arthroscopy) History of septic arthritis or active infection History of malignancy Severe systemic diseases (e.g., advanced cardiac, renal, or hepatic failure) Neuromuscular disorders affecting lower extremity function Intra-articular injection (e.g., corticosteroids, PRP) within the last 3 months Other conditions that may cause knee pain apart from osteoarthritis Cognitive or psychiatric conditions preventing compliance with study procedures Refusal to provide informed consent
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 |
|---|---|---|
| Observational StudyThis is an observational study with no intervention. Participants will undergo clinical, radiological, and laboratory assessments, including serum biomarker analysis, without any therapeutic or experimental intervention. | Other | Healthy Control, Knee Osteoarthritis |
Primary outcome
Serum COMP and MMP-3 Levels
Time frame: At baseline
Serum levels of cartilage oligomeric matrix protein (COMP) and matrix metalloproteinase-3 (MMP-3) will be measured using ELISA. The association between biomarker levels and clinical (VAS, WOMAC), functional (5 Times Sit-to-Stand Test), and radiological (Kellgren-Lawrence grade) severity parameters will be evaluated.
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 14 Apr 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Kanuni Sultan Suleyman Training and Research Hospital.
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: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Zeynep Karakuzu Güngör, M.D (905077750375, zeynepkarakuzu@hotmail.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum COMP and MMP-3 Levels (time frame: At baseline). 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 14 Apr 2026.