- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05955573
Knee Osteoarthritis, Aging and Metabolic Syndrome
March 17, 2024 updated by: Amany Mohamed Abdelrahman, Sohag University
What Affects the Severity of Knee Osteoarthritis? Aging or Associated Metabolic Syndrome
Osteoarthritis (OA) is the most prevalent form of arthritis.
Its pathogenesis remains poorly understood.
Though historically regarded as a disease of mechanical degeneration, it is now appreciated that inflammation plays an important role in OA pathogenesis
Study Overview
Detailed Description
- Place of the study: Sohag university hospital.
- Type of study: Cross-Sectional Observational study
- Study period: Six months to one year The study will include Patients who met the American College of Rheumatology (ACR) clinical criteria for knee OA .
The following details will be obtained:
Demographic data : Age ,Sex ,Marital status ,Occupation ,Residence ,Education level
,Anthropometrical measures which included waist circumference (WC) and blood pressure (BP) will be obtained,History of chronic diseases (eg; Diabetes mellites, Hypertension)
- Clinical information: Symptom and its Duration. Plain radiographs of at least one knee [anteroposterior (A/P), lateral} will be taken.
- Laboratory findings included fasting blood sugar, serum levels of triglycerides, High-density lipoprotein cholesterol and total cholesterol.
Study Type
Observational
Enrollment (Estimated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Amany Mohamed abdelrahman, master
- Phone Number: 01066706352
- Email: amanymohamed@med.sohag.edu.eg
Study Contact Backup
- Name: Hanan Sayed Abo-zaid, MD
- Phone Number: 01150532194
Study Locations
-
-
-
Sohag, Egypt
- Recruiting
- Sohag faculty of medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
knee osteoartgritis
Description
Inclusion Criteria:
- Patients who met the American College of Rheumatology (ACR) clinical criteria for knee OA and had symptomatic OA of at least 1 knee (index knee), with a Kellgren / Lawrence (K/L) score ≥ 1 in that knee
Exclusion Criteria:
Any patient with a history of trauma to the knee
- Any other form of arthritis (e.g., rheumatoid arthritis, seronegative spondyloarthropathies, gout, pyrophosphate disease, or other crystal arthropathy)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
knee osteoarthritis
Knee osteoarthritis
|
radiological description
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
severity of knee osteoarthritis
Time Frame: 8/2023-8/2024
|
Kellgren and Lawrence (K/L) grading system of Knee osteoarthritis.
It assigned a grade from 0 to 4, which they correlated to increasing severity of OA, with Grade 0 signifying no presence of OA and Grade 4 signifying severe OA .
|
8/2023-8/2024
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Dalia Shaker Elgendy, MD, Sohag University
- Study Director: Hanan Sayed Abo-zaid, MD, Sohag University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Krasnokutsky S, Oshinsky C, Attur M, Ma S, Zhou H, Zheng F, Chen M, Patel J, Samuels J, Pike VC, Regatte R, Bencardino J, Rybak L, Abramson S, Pillinger MH. Serum Urate Levels Predict Joint Space Narrowing in Non-Gout Patients With Medial Knee Osteoarthritis. Arthritis Rheumatol. 2017 Jun;69(6):1213-1220. doi: 10.1002/art.40069. Epub 2017 Apr 28.
- Englund, M. (202+3). Osteoarthritis, part of life or a curable disease? A bird's-eye view. In Journal of Internal Medicine. John Wiley and Sons Inc. https://doi.org/10.1111/joim.13634 Grundy, S. M., Cleeman, J. I., Daniels, S. R., Donato, K. A., Eckel, R. H., Franklin, B. A., Gordon, D. J., Krauss, R. M., Savage, P. J., Smith, S. C., Spertus, J. A., & Costa, F. (2005). Diagnosis and management of the metabolic syndrome: An American Heart Association/National Heart, Lung, and Blood Institute scientific statement. In Circulation (Vol. 112, Issue 17, pp. 2735-2752). https://doi.org/10.1161/CIRCULATIONAHA.105.169404 KELLGREN, J. H., & LAWRENCE, J. S. (1957). Radiological assessment of osteo-arthrosis. Annals of the Rheumatic Diseases, 16(4), 494-502. https://doi.org/10
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 20, 2023
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
August 1, 2024
Study Registration Dates
First Submitted
July 13, 2023
First Submitted That Met QC Criteria
July 13, 2023
First Posted (Actual)
July 21, 2023
Study Record Updates
Last Update Posted (Actual)
March 19, 2024
Last Update Submitted That Met QC Criteria
March 17, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-23-07-17MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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