NCT07153315

Brief Summary

This study aims to evaluate the diagnostic accuracy of AI-assisted imaging analysis in differentiating between inflammatory and degenerative joint diseases in elderly patients. The performance of AI-based analysis will be compared with radiologists' assessments to determine its reliability in clinical practice. In addition, the study will explore imaging features most predictive of each disease type using advanced machine learning techniques. Finally, the feasibility of implementing AI tools in the routine management of geriatric musculoskeletal disorders will be assessed.

Trial Health

63
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Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
not yet 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

Study Progress63%
Sep 2025Oct 2026

First Submitted

Initial submission to the registry

August 25, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

September 3, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

August 25, 2025

Last Update Submit

August 29, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of AI system

    Sensitivity, specificity, and AUC of AI algorithm for differentiating inflammatory from degenerative joint diseases, using imaging data, compared to expert rheumatologist diagnosis

    Within 12 months from baseline assessment.

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly patients (≥60 years) presenting to Assiut University Hospitals with clinical suspicion or diagnosis of musculoskeletal disorders, specifically inflammatory joint diseases (such as rheumatoid arthritis) or degenerative joint diseases (such as osteoarthritis), and who have relevant imaging studies (X-ray, MRI, or ultrasound) available for analysis.

You may qualify if:

  • Age ≥ 60 years
  • Clinical suspicion or confirmed diagnosis of inflammatory joint disease (e.g., rheumatoid arthritis, psoriatic arthritis) or degenerative joint disease (e.g., osteoarthritis)
  • Availability of relevant musculoskeletal imaging (X-rays, MRI, or ultrasound) suitable for AI-based analysis
  • Ability to provide informed consent or have a legal representative consent on behalf of the

You may not qualify if:

  • History of recent joint trauma (within the last 6 months) or previous joint surgery affecting the studied sites
  • Presence of bone or joint malignancy (primary or metastatic)
  • Diagnosis of overlapping rheumatologic syndromes or mixed pathology (e.g., RA with concurrent gout, or OA with inflammatory overlap)
  • Inadequate imaging quality or absence of required imaging modalities
  • Inability or unwillingness to provide informedconsent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, 71515, Egypt

Location

Related Publications (3)

  • Bhaumik S. Cardiologists are putting in stents needlessly, doctors say. BMJ. 2013 Feb 4;346:f739. doi: 10.1136/bmj.f739. No abstract available.

    PMID: 23381588BACKGROUND
  • Schmidhuber J. Deep learning in neural networks: an overview. Neural Netw. 2015 Jan;61:85-117. doi: 10.1016/j.neunet.2014.09.003. Epub 2014 Oct 13.

    PMID: 25462637BACKGROUND
  • Litjens G, Kooi T, Bejnordi BE, Setio AAA, Ciompi F, Ghafoorian M, van der Laak JAWM, van Ginneken B, Sanchez CI. A survey on deep learning in medical image analysis. Med Image Anal. 2017 Dec;42:60-88. doi: 10.1016/j.media.2017.07.005. Epub 2017 Jul 26.

    PMID: 28778026BACKGROUND

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Mohamed Mahmoud Mohamed, Resident at internal medicine

    Assiut University Hospitals - Faculty of Medicine, Assiut University, Egypt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Mahmoud Mohamed

CONTACT

Prof/soheir Mostafa Kasem, Professor of Internal Medicine

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

August 25, 2025

First Posted

September 3, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

September 3, 2025

Record last verified: 2025-08

Locations