Clinical trial NCT05456711: Femoral Cartilage Thickness in Knee Osteoarthritis
Official title: Investigation of the Relationship Between Femoral Cartilage Thickness and Inflammatory Parameters, Pain Severity and Functionality in Knee Osteoarthiritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Osteoarthritis
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 140
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: ultrasonography
timeFrame: 1 day
measure: Visual Analog Scale
timeFrame: 1 day
measure: Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: 1 day
measure: neutrophil account
timeFrame: 1 day
measure: lymphocyte account
timeFrame: 1 day
measure: monocyte account
timeFrame: 1 day
measure: platelet account
timeFrame: 1 day
measure: eritrocyte sedimentation rate
timeFrame: 1 day
measure: C-reactive protein
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Suleyman Training and Research Hospital
state: Kucukcekmece
Study officials:
affiliation: Kanuni Sultan Suleyman Training and Research Hospital
name: Merve D. Korkmaz, M.D.
role: PRINCIPAL_INVESTIGATOR
References: