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Characteristics of Rheumatoid Arthritis Patients With Atlantoaxial Synovitis Detected by Plain X-ray and MRI (MRI)

Primary Purpose

Neck Pain

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Plain X-ray

Magnetic resonance imaging

About this trial

This is an interventional screening trial for Neck Pain focused on measuring AAJ RA MRI synovitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Rheumatoid arthritis patients complaining or not complaining of atlantoaxial affection symptomatology

Exclusion Criteria:

Pregnant females
Patients with pacemakers or metallic bony plates.
Patients that have claustrophobia

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Symptomatic atlantoaxial joint affection

Asymptomatic atlantoaxial joint aff.

Arm Description

Undergo plain X-ray and magnetic resonance imaging

Outcomes

Primary Outcome Measures

Prevelance of atlantoaxial joint affection in clinically and laboratory proven rheumatoid arthritis patients

Prevelance of atlantoaxial joint affection in symptomatic versus asymptomatic rheumatoid arthritis patients

Secondary Outcome Measures

Full Information

NCT ID

NCT02774070

First Posted

May 11, 2016

Last Updated

January 11, 2020

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT02774070

Brief Title

Characteristics of Rheumatoid Arthritis Patients With Atlantoaxial Synovitis Detected by Plain X-ray and MRI

Acronym

MRI

Official Title

Characteristics of Rheumatoid Arthritis Patients With Asymptomatic Versus Symptomatic Atlantoaxial Joint Affection Detected by Plain X-ray and Magnetic Resonance Imaging

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Withdrawn

Why Stopped

No financial support

Study Start Date

October 2016 (undefined)

Primary Completion Date

January 2017 (Anticipated)

Study Completion Date

February 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study detects the presence of atlantoaxial joint affection in symptomatic versus asymptomatic rheumatoid arthritis patients revealed by plain X-ray and magnetic resonance imaging of the cervical spine

Detailed Description

Atlantoaxial joint affection in rheumatoid arthritis patients may have life-threatening complications if not detected early. It may not be detected unless it becomes symptomatic. However, asymptomatic atlantoaxial joint affection is not uncommon. Investigators will try to detect atlantoaxial joint affection at an early stage and its relation to symptomatology and other disease criteria. So investigators will use conventional plain X-ray examination combined with magnetic resonance imaging of the cervical spine to detect soft tissue as well as bony changes of this condition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neck Pain

Keywords

AAJ RA MRI synovitis

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Symptomatic atlantoaxial joint affection

Arm Type

Other

Arm Description

Undergo plain X-ray and magnetic resonance imaging

Arm Title

Asymptomatic atlantoaxial joint aff.

Arm Type

Other

Arm Description

Undergo plain X-ray and magnetic resonance imaging

Intervention Type

Radiation

Intervention Name(s)

Plain X-ray

Intervention Description

antero-posterior, lateral neutral, flexion, extension and open-mouth views

Intervention Type

Radiation

Intervention Name(s)

Magnetic resonance imaging

Intervention Description

Magnetic resonance imaging sagittal T1W,T2W and STIR, axial T1W and coronal T2W and post contrast sagittal and axial sequences

Primary Outcome Measure Information:

Title

Prevelance of atlantoaxial joint affection in clinically and laboratory proven rheumatoid arthritis patients

Description

Prevelance of atlantoaxial joint affection in symptomatic versus asymptomatic rheumatoid arthritis patients

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Rheumatoid arthritis patients complaining or not complaining of atlantoaxial affection symptomatology Exclusion Criteria: Pregnant females Patients with pacemakers or metallic bony plates. Patients that have claustrophobia

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nisreen A Abbas, Doctor

Organizational Affiliation

Assiut University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

24558457

Citation

Yurube T, Sumi M, Nishida K, Miyamoto H, Kohyama K, Matsubara T, Miura Y, Hirata H, Sugiyama D, Doita M. Accelerated development of cervical spine instabilities in rheumatoid arthritis: a prospective minimum 5-year cohort study. PLoS One. 2014 Feb 18;9(2):e88970. doi: 10.1371/journal.pone.0088970. eCollection 2014.

Results Reference

background

PubMed Identifier

25130155

Citation

Nazarinia M, Jalli R, Kamali Sarvestani E, Farahangiz S, Ataollahi M. Asymptomatic atlantoaxial subluxation in rheumatoid arthritis. Acta Med Iran. 2014;52(6):462-6.

Results Reference

background

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Characteristics of Rheumatoid Arthritis Patients With Atlantoaxial Synovitis Detected by Plain X-ray and MRI

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