Femoral Cartilage Thickness in Knee Osteoarthritis

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

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Diagnostic test: ultrasonographic measurement for femoral cartilage thickness VAS for pain severity WOMAC for functionality

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 Type: Observational
• Enrollment (Anticipated): 140

Contacts and Locations

• Study Contact: Name: Merve D. Korkmaz, M.D.; Phone Number: +905556297264; Email: mervedml@gmail.com

Study Locations

• Turkey
  • Kucukcekmece
    • Istanbul, Kucukcekmece, Turkey, 34303
      • Recruiting
      • Kanuni Sultan Suleyman Training and Research Hospital
      • Contact: Merve D Korkmaz, M.D.; Phone Number: +905556297264; Email: mervedml@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
knee osteoarthritis; ultrasonographic measurement for femoral cartilage thickness VAS for pain severity WOMAC for functionality	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
healthy control; ultrasonographic measurement for femoral cartilage thickness VAS for pain severity WOMAC for functionality	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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital
• Investigators: Principal Investigator: Merve D. Korkmaz, M.D., Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2022
• Primary Completion (Anticipated): July 15, 2022
• Study Completion (Anticipated): July 15, 2022

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): July 13, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: KAEK/2022.05.103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No