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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05955573
Other study ID # Soh-Med-23-07-17MS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 20, 2023
Est. completion date August 2024

Study information

Verified date March 2024
Source Sohag University
Contact Amany Mohamed abdelrahman, master
Phone 01066706352
Email amanymohamed@med.sohag.edu.eg
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


Description:

1. Place of the study: Sohag university hospital. 2. Type of study: Cross-Sectional Observational study 3. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date August 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 30 Years and older
Eligibility 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 Design


Intervention

Diagnostic Test:
xray
radiological description

Locations

Country Name City State
Egypt Sohag Faculty of Medicine Sohag

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary severity of knee osteoarthritis 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
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