NCT05955573

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

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

July 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

August 20, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

March 19, 2024

Status Verified

March 1, 2024

Enrollment Period

10 months

First QC Date

July 13, 2023

Last Update Submit

March 17, 2024

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritisAgingMetabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

knee osteoarthritis

Knee osteoarthritis

Diagnostic Test: xray

Interventions

xrayDIAGNOSTIC_TEST

radiological description

knee osteoarthritis

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

knee osteoartgritis

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag Faculty of Medicine

Sohag, Egypt

RECRUITING

Related 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

    BACKGROUND

  • 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.

    PMID: 28217895BACKGROUND

Related Links

MeSH Terms

Conditions

Osteoarthritis, KneeMetabolic Syndrome

Interventions

X-Rays

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • Dalia Shaker Elgendy, MD

    Sohag University

    STUDY CHAIR

  • Hanan Sayed Abo-zaid, MD

    Sohag University

    STUDY DIRECTOR

Central Study Contacts

Amany Mohamed abdelrahman, master

CONTACT

01066706352amanymohamed@med.sohag.edu.eg

Hanan Sayed Abo-zaid, MD

CONTACT

01150532194

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Medicine, Rheumatology and Rehabilitation Department

Study Record Dates

First Submitted

July 13, 2023

First Posted

July 21, 2023

Study Start

August 20, 2023

Primary Completion

June 1, 2024

Study Completion

August 1, 2024

Last Updated

March 19, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)