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Knee Osteoarthritis, Aging and Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT05955573
Recruitment Status : Recruiting
First Posted : July 21, 2023
Last Update Posted : March 19, 2024
Sponsor:
Information provided by (Responsible Party):
Amany Mohamed Abdelrahman, Sohag University

Study Description
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Brief 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

Condition or disease Intervention/treatment
Knee Osteoarthritis Diagnostic Test: xray

Detailed 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.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Month
Official Title: What Affects the Severity of Knee Osteoarthritis? Aging or Associated Metabolic Syndrome
Actual Study Start Date : August 20, 2023
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays

Groups and Cohorts
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Group/Cohort Intervention/treatment
knee osteoarthritis
Knee osteoarthritis
 Diagnostic Test: xray
radiological description


Outcome Measures
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Primary Outcome Measures :
  1. 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 .


Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
knee osteoartgritis
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05955573


Contacts
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Contact: Amany Mohamed abdelrahman, master 01066706352 amanymohamed@med.sohag.edu.eg
Contact: Hanan Sayed Abo-zaid, MD 01150532194

Locations
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Egypt
Sohag Faculty of Medicine Recruiting
Sohag, Egypt
Sponsors and Collaborators
Sohag University
Investigators
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Study Chair: Dalia Shaker Elgendy, MD Sohag University
Study Director: Hanan Sayed Abo-zaid, MD Sohag University
More Information
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Additional Information:

Publications:
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

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Responsible Party: Amany Mohamed Abdelrahman, Physical Medicine, Rheumatology and Rehabilitation Department, Sohag University
ClinicalTrials.gov Identifier: NCT05955573    
Other Study ID Numbers: Soh-Med-23-07-17MS
First Posted: July 21, 2023    Key Record Dates
Last Update Posted: March 19, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amany Mohamed Abdelrahman, Sohag University:
knee osteoarthritis
Aging
Metabolic Syndrome
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Metabolic Syndrome
Arthritis
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases