Knee OsteoarthritisNCT05456711
Femoral Cartilage Thickness in Knee Osteoarthritis
An observational study of Knee Osteoarthritis, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study to investigate the relationship between femoral cartilage thickness in Ultrasonographic evaluation and inflammatory parameters, pain severity and functionality in participants with Knee Osteoarthritis Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- ultrasonographic measurement for femoral cartilage thickness VAS for pain severity WOMAC for functionality
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2022to 15 Jul 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 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: aged between 50-65 years, female and male, diagnosed as knee osteoarthritis for study group and having no symptoms for knee OA for control group
Who may be able to join
- diagnosed as knee osteoarthritis
- aged between 50-65 years
- volunteer to participate in the study
Who cannot join
- limitation of cooperation
- moderate to severe dementia or mental retardation, which may cause limitations in examination, testing and treatment
- refusal to participate in the study
- pprevious total knee prosthesis surgery
- secondary osteoarthritis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, Kucukcekmece, 34303
Merve D Korkmaz, M.D., +905556297264, mervedml@gmail.com
About this study
Official title: Investigation of the Relationship Between Femoral Cartilage Thickness and Inflammatory Parameters, Pain Severity and Functionality in Knee Osteoarthiritis
The aim of the study to investigate the relationship between femoral cartilage thickness in Ultrasonographic evaluation and inflammatory parameters, pain severity and functionality in participants with Knee Osteoarthritis
Read the detailed description
Aim: The aim of the study is to investigate the relationship between femoral cartilage thickness and inflammatory parameters, pain severity and functionality in participants with Knee Osteoarthritis.
Methods: This study is designed as a prospective, cross-sectional trial. 90 participants aged between 50-65 years with knee osteoarthritis(OA) and at least 50 participants without any symptom for knee OA are included in the study in accordance with the inclusion criteria. Participants' demographic characteristics will be evaluated, and ultrasonographic measurement will be performed for measuring femoral cartilage thickness. Visual Analog scale will be used for pain severity and Western Ontario and McMaster Universities Osteoartrit index (WOMAC) will be used for assessing functionality of the patients. Also hematologic parameters(neutrophils, leucocytes, lymphocytes, platelet, CRP, erythrocyte sedimentation rate) will be evaluated for investigating the inflammation. The relationship between femoral cartilage thickness and inflammatory parameters, pain severity and functionality in knee osteoarthritis will be analysed for both group.
- Conditions
- Knee Osteoarthritis
- Being tested
- ultrasonographic measurement for femoral cartilage thickness VAS for pain severity WOMAC for functionality
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographic measurement for femoral cartilage thickness VAS for pain severity WOMAC for functionalityDiagnostic test
ultrasonographic measurement for femoral cartilage thickness VAS for pain severity WOMAC for functionality
| Study group | Role | What they receive |
|---|---|---|
| knee osteoarthritis | ultrasonographic measurement for femoral cartilage thickness VAS for pain severity WOMAC for functionality Receives: Diagnostic Test: ultrasonographic measurement for femoral cartilage thickness VAS for pain severity WOMAC for functionality | |
| healthy control | ultrasonographic measurement for femoral cartilage thickness VAS for pain severity WOMAC for functionality Receives: Diagnostic Test: ultrasonographic measurement for femoral cartilage thickness VAS for pain severity WOMAC for functionality |
What is being measured
The primary outcome is the main question the study is designed to answer.
ultrasonography
measurement of femoral cartilage thickness
Measured: 1 day
Visual Analog Scale
evaluation of pain severity
Measured: 1 day
Western Ontario and McMaster Universities Osteoarthritis Index
evaluation of functionality
Measured: 1 day
neutrophil account
neutrophil account
Measured: 1 day
lymphocyte account
lymphocyte account
Measured: 1 day
monocyte account
monocyte account
Measured: 1 day
platelet account
platelet account
Measured: 1 day
eritrocyte sedimentation rate
eritrocyte sedimentation rate
Measured: 1 day
C-reactive protein
C-reactive protein
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 posted13 Jul 2022
- Study start15 May 2022
- Primary completion15 Jul 2022 (estimated)
- Study completion15 Jul 2022 (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
- Other
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Damla Korkmaz, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Merve D. Korkmaz, M.D., Principal investigator, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456711
- Sponsor's protocol ID
- KAEK/2022.05.103
- Status last verified
- Jul 2022
- First submitted
- 22 Jun 2022
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Femoral Cartilage Thickness and Inflammatory Parameters, Pain Severity and Functionality in Knee Osteoarthiritis
- ClinicalTrials.gov ID
- NCT05456711
- Acronym / sponsor ID
- KAEK/2022.05.103
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 15 May 2022 (actual)
- Primary completion
- 15 Jul 2022 (estimated)
- Study completion
- 15 Jul 2022 (estimated)
- First posted
- 13 Jul 2022 (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 aim of the study to investigate the relationship between femoral cartilage thickness in Ultrasonographic evaluation and inflammatory parameters, pain severity and functionality in participants with Knee Osteoarthritis
Detailed description
Aim: The aim of the study is to investigate the relationship between femoral cartilage thickness and inflammatory parameters, pain severity and functionality in participants with Knee Osteoarthritis.
Methods: This study is designed as a prospective, cross-sectional trial. 90 participants aged between 50-65 years with knee osteoarthritis(OA) and at least 50 participants without any symptom for knee OA are included in the study in accordance with the inclusion criteria. Participants' demographic characteristics will be evaluated, and ultrasonographic measurement will be performed for measuring femoral cartilage thickness. Visual Analog scale will be used for pain severity and Western Ontario and McMaster Universities Osteoartrit index (WOMAC) will be used for assessing functionality of the patients. Also hematologic parameters(neutrophils, leucocytes, lymphocytes, platelet, CRP, erythrocyte sedimentation rate) will be evaluated for investigating the inflammation. The relationship between femoral cartilage thickness and inflammatory parameters, pain severity and functionality in knee osteoarthritis will be analysed for both group.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| knee osteoarthritis | – | Diagnostic Test: ultrasonographic measurement for femoral cartilage thickness VAS for pain severity WOMAC for functionalityultrasonographic measurement for femoral cartilage thickness VAS for pain severity WOMAC for functionality |
| healthy control | – | Diagnostic Test: ultrasonographic measurement for femoral cartilage thickness VAS for pain severity WOMAC for functionalityultrasonographic measurement for femoral cartilage thickness VAS for pain severity WOMAC for functionality |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- aged between 50-65 years, female and male, diagnosed as knee osteoarthritis for study group and having no symptoms for knee OA for control group
Key inclusion criteria (3 listed)
- diagnosed as knee osteoarthritis
- aged between 50-65 years
- volunteer to participate in the study
Key exclusion criteria (5 listed)
- limitation of cooperation
- moderate to severe dementia or mental retardation, which may cause limitations in examination, testing and treatment
- refusal to participate in the study
- pprevious total knee prosthesis surgery
- secondary osteoarthritis
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 |
|---|---|---|
| ultrasonographic measurement for femoral cartilage thickness VAS for pain severity WOMAC for functionalityultrasonographic measurement for femoral cartilage thickness VAS for pain severity WOMAC for functionality | Diagnostic test | healthy control, knee osteoarthritis |
Primary outcome
ultrasonography
Time frame: 1 day
measurement of femoral cartilage thickness
Visual Analog Scale
Time frame: 1 day
evaluation of pain severity
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: 1 day
evaluation of functionality
neutrophil account
Time frame: 1 day
neutrophil account
lymphocyte account
Time frame: 1 day
lymphocyte account
monocyte account
Time frame: 1 day
monocyte account
platelet account
Time frame: 1 day
platelet account
eritrocyte sedimentation rate
Time frame: 1 day
eritrocyte sedimentation rate
C-reactive protein
Time frame: 1 day
C-reactive protein
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Knee Osteoarthritis
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Holistic Healing for Knee Osteoarthritis
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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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. This study is not recruiting at the moment.
Merve D. Korkmaz, M.D. principal investigator
Kanuni Sultan Suleyman Training and Research Hospital
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, run by Kanuni Sultan Suleyman 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Merve D. Korkmaz, M.D. (+905556297264, mervedml@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ultrasonography (time frame: 1 day). The study lists 9 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 13 Jul 2022.