NCT05456711

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 22, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 13, 2022

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
Last Updated

July 13, 2022

Status Verified

July 1, 2022

Enrollment Period

2 months

First QC Date

June 22, 2022

Last Update Submit

July 11, 2022

Conditions

Outcome Measures

Primary Outcomes (9)

  • 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

Study Arms (2)

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

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

Interventions

ultrasonographic measurement for femoral cartilage thickness VAS for pain severity WOMAC for functionality

healthy controlknee osteoarthritis

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • diagnosed as knee osteoarthritis
  • aged between 50-65 years
  • volunteer to participate in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Kucukcekmece, 34303, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Merve D. Korkmaz, M.D.

    Kanuni Sultan Suleyman Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Merve D. Korkmaz, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

June 22, 2022

First Posted

July 13, 2022

Study Start

May 15, 2022

Primary Completion

July 15, 2022

Study Completion

July 15, 2022

Last Updated

July 13, 2022

Record last verified: 2022-07

Locations