- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02774070
Characteristics of Rheumatoid Arthritis Patients With Atlantoaxial Synovitis Detected by Plain X-ray and MRI (MRI)
January 11, 2020 updated by: Nisreen Adel Abbas, Assiut University
Characteristics of Rheumatoid Arthritis Patients With Asymptomatic Versus Symptomatic Atlantoaxial Joint Affection Detected by Plain X-ray and Magnetic Resonance Imaging
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
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Not Applicable
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Symptomatic atlantoaxial joint affection
Undergo plain X-ray and magnetic resonance imaging
|
antero-posterior, lateral neutral, flexion, extension and open-mouth views
Magnetic resonance imaging sagittal T1W,T2W and STIR, axial T1W and coronal T2W and post contrast sagittal and axial sequences
|
|
Other: Asymptomatic atlantoaxial joint aff.
Undergo plain X-ray and magnetic resonance imaging
|
antero-posterior, lateral neutral, flexion, extension and open-mouth views
Magnetic resonance imaging sagittal T1W,T2W and STIR, axial T1W and coronal T2W and post contrast sagittal and axial sequences
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevelance of atlantoaxial joint affection in clinically and laboratory proven rheumatoid arthritis patients
Time Frame: 3 months
|
Prevelance of atlantoaxial joint affection in symptomatic versus asymptomatic rheumatoid arthritis patients
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nisreen A Abbas, Doctor, Assiut 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
- 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.
- 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.
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
October 1, 2016
Primary Completion (Anticipated)
January 1, 2017
Study Completion (Anticipated)
February 1, 2017
Study Registration Dates
First Submitted
May 11, 2016
First Submitted That Met QC Criteria
May 12, 2016
First Posted (Estimate)
May 17, 2016
Study Record Updates
Last Update Posted (Actual)
January 14, 2020
Last Update Submitted That Met QC Criteria
January 11, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Rheumatoid AAJ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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