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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05456711
Other study ID # KAEK/2022.05.103
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 15, 2022
Est. completion date July 15, 2022

Study information

Verified date July 2022
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact Merve D. Korkmaz, M.D.
Phone +905556297264
Email mervedml@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date July 15, 2022
Est. primary completion date July 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 65 Years
Eligibility Inclusion Criteria: - diagnosed as knee osteoarthritis - aged between 50-65 years - volunteer to participate in the study Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
ultrasonographic measurement for femoral cartilage thickness VAS for pain severity WOMAC for functionality
ultrasonographic measurement for femoral cartilage thickness VAS for pain severity WOMAC for functionality

Locations

Country Name City State
Turkey Kanuni Sultan Suleyman Training and Research Hospital Istanbul Kucukcekmece

Sponsors (1)

Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary ultrasonography measurement of femoral cartilage thickness 1 day
Primary Visual Analog Scale evaluation of pain severity 1 day
Primary Western Ontario and McMaster Universities Osteoarthritis Index evaluation of functionality 1 day
Primary neutrophil account neutrophil account 1 day
Primary lymphocyte account lymphocyte account 1 day
Primary monocyte account monocyte account 1 day
Primary platelet account platelet account 1 day
Primary eritrocyte sedimentation rate eritrocyte sedimentation rate 1 day
Primary C-reactive protein C-reactive protein 1 day
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