Carpal Bone Erosion in Rheumatoid Arthritis :Diagnostic Value

August 17, 2024 updated by: Abeer Abdelaal Aly, Sohag University
Rheumatoid arthritis (RA) is a systemic inflammatory disease characterized by proliferative hyper vascularized synovitis which primarily affects synovial joints. Synovium of bursa; tendon sheaths; attachment sites of cartilage, ligament, and tendons to the bone; soft tissue; and bones can be mentioned among the other areas under influence of RA. Changes happen to be symmetrical and may present as fusiform soft tissue swelling, regional osteoporosis, marginal-central erosions, cartilage damage, joint destruction, narrowing of joint space and fibrous ankyloses. Wrist, metacarpophalangeal and metatarsophalangeal joints are the first sites to be affected .Over the past few years, an increasing number of rheumatologists have started to use US in the clinical setting of the early arthritis clinic. While US allows for an accurate and non-invasive multisite assessment of joint involvement in patients with RA, time for US examination is not infinite

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

110

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

Study Contact Backup

  • Name: ahmed M mahrous, Professor

Study Locations

  • Egypt
      • Sohag, Egypt
        • Sohag University hospitals
        • Contact:
          • Magdy Amin, Professor

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

N/A

Sampling Method

Probability Sample

Study Population

  1. RA patients fulfilled the 2010 American College of Rheumatoid Arthritis classification criteria.[8]
  2. SLE patients fulfilled the 2019 ACR\EULAR classification criteria for SLE.[9]
  3. Age above 18 years old.
  4. Patient cooperative and can answer questions.
  5. Patients who are able and willing to give written informed consent

Description

Inclusion Criteria:

  • 1. RA patients fulfilled the 2010 American College of Rheumatoid Arthritis classification criteria.[8] 2. SLE patients fulfilled the 2019 ACR\EULAR classification criteria for SLE.[9] 3. Age above 18 years old. 4. Patient cooperative and can answer questions. 5. Patients who are able and willing to give written informed consent.

Exclusion Criteria:

  • 1. Age below 18 years and above 60 years. 2. Uncooperative patients. 3. Patient not able and willing to give written informed consent.

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
controls
healthy controls
Radiation: musculoskeletal ultrasound
musculoskeletal ultrasound on both hands
cases
rheumatoid arthriris patients
Radiation: musculoskeletal ultrasound
musculoskeletal ultrasound on both hands
control
systemic lupus patients
Radiation: musculoskeletal ultrasound
musculoskeletal ultrasound on both hands

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone erosion
Time Frame: max 1 year
erosions in carpal bones and MCP 2,5 in both hands
max 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

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 (Estimated)

August 15, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

August 17, 2024

First Submitted That Met QC Criteria

August 17, 2024

First Posted (Actual)

August 20, 2024

Study Record Updates

Last Update Posted (Actual)

August 20, 2024

Last Update Submitted That Met QC Criteria

August 17, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • soh-med-24-07-10MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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