- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05456711
Femoral Cartilage Thickness in Knee Osteoarthritis
Investigation of the Relationship Between Femoral Cartilage Thickness and Inflammatory Parameters, Pain Severity and Functionality in Knee Osteoarthiritis
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Merve D. Korkmaz, M.D.
- Telefonnummer: +905556297264
- E-mail: mervedml@gmail.com
Studiesteder
-
-
Kucukcekmece
-
Istanbul, Kucukcekmece, Kalkun, 34303
- Rekruttering
- Kanuni Sultan Suleyman Training and Research Hospital
-
Kontakt:
- Merve D Korkmaz, M.D.
- Telefonnummer: +905556297264
- E-mail: mervedml@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
knee osteoarthritis
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
|
ultrasonographic measurement for femoral cartilage thickness VAS for pain severity WOMAC for functionality
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
ultrasonography
Tidsramme: 1 day
|
measurement of femoral cartilage thickness
|
1 day
|
|
Visual Analog Scale
Tidsramme: 1 day
|
evaluation of pain severity
|
1 day
|
|
Western Ontario and McMaster Universities Osteoarthritis Index
Tidsramme: 1 day
|
evaluation of functionality
|
1 day
|
|
neutrophil account
Tidsramme: 1 day
|
neutrophil account
|
1 day
|
|
lymphocyte account
Tidsramme: 1 day
|
lymphocyte account
|
1 day
|
|
monocyte account
Tidsramme: 1 day
|
monocyte account
|
1 day
|
|
platelet account
Tidsramme: 1 day
|
platelet account
|
1 day
|
|
eritrocyte sedimentation rate
Tidsramme: 1 day
|
eritrocyte sedimentation rate
|
1 day
|
|
C-reactive protein
Tidsramme: 1 day
|
C-reactive protein
|
1 day
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Merve D. Korkmaz, M.D., Kanuni Sultan Suleyman Training and Research Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- KAEK/2022.05.103
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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