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Anterior Shoulder US - a New Access

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ClinicalTrials.gov Identifier: NCT01746966
Recruitment Status : Unknown
Verified May 2014 by Rambam Health Care Campus.
Recruitment status was:  Recruiting
First Posted : December 11, 2012
Last Update Posted : May 6, 2014
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus

Brief Summary:
  1. Investigate Gleno-Humeral Joint (GHJ) by anterior approach:

    A - Measurement of GHJ thickness at 3 points and average value calculation on body supine position and with arm supinated, maximal externally rotated with elbow angle 90 degrees

    • By longitudinal access with transducer position laterally to coracoids along to the GHJ line, located as diagonal form lower to forward and lateral direction with demonstration the joint cartilage posteriorly and subscapular tendon anteriorly (Fig.4)
    • By transversal access with 90 degrees to longitudinal and at 3 points: upper with coracoids visualization, middle and lower (Fig.5-7).

    B - Measurement of rotator interval with assessment of width and higher.

  2. Comparison of the data with results of classic values have been received by posterior and inferior (axillar) approach.
  3. Comparison of the results between patients with Rheumatoid Arthritis (RA) and healthy controls

Condition or disease
Rheumatoid Arthritis

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: US Investigation of Gleno-humeral Joint by Anterior Access With Measurement of Rotator Interval in Patients With Rheumatoid Arthritis and Healthy Controls
Study Start Date : December 2012
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Group/Cohort
Rheumatoid Arthritis
20 patients age of 20-60 with Rheumatoid Arthritis according to ARA 1987 revised criteria and disease activity Disease Activity Score (DAS) 3-5
Healthy controls participants
Healthy controls age of 20-60 according to conclusion of preventive medicine department



Primary Outcome Measures :
  1. Measurement of GHJ thickness and of rotator interval [ Time Frame: Six months ]

    A - Measurement of GHJ thickness at 3 points and average value calculation on body supine position and with arm supinated, maximal externally rotated with elbow angle 90 degrees

    • By longitudinal access with transducer position laterally to coracoids along to the GHJ line, located as diagonal form lower to forward and lateral direction with demonstration the joint cartilage posteriorly and subscapular tendon anteriorly (Fig.4)
    • By transversal access with 90 degrees to longitudinal and at 3 points: upper with coracoids visualization, middle and lower (Fig.5-7).

    B - Measurement of rotator interval with with assessment of width and higher.



Secondary Outcome Measures :
  1. Data of comparison between measurement of GHJ in anterior and axillar access and anterior and posterior access in patients with Rheumatoid Arthritis and Controls. [ Time Frame: Eight months ]
  2. Data of comparison in measurement of rotator interval in patients with Rheumatoid Arthritis and controls. [ Time Frame: Eight months ]


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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
20 healthy controls from department of preventive medicine and 20 patients with Rheumatoid Arthritis age of 20-60
Criteria

Inclusion Criteria:

  1. Healthy controls age of 20-60 according to conclusion of preventive medicine department
  2. Patients with RA according to ARA 1987 revised criteria and disease activity DAS 3-5

Exclusion Criteria:

  1. Past shoulder trauma
  2. Shoulder osteoarthritis
  3. Rotator cuff disorders
  4. Shoulder injections
  5. Cervical spondylosis with nerve root compression, Cervical symptomatic disc syndromes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01746966


Contacts
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Contact: Alexander Rozin, MD 972-48542268 a_rozin@rambam.health.gov.il

Locations
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Israel
Rheumatology unit Recruiting
Haifa, Israel, 31096
Contact: Alexander Rozin, MD    972-48542268    a_rozin@rambam.health.gov.il   
Sub-Investigator: Amir Dagan, MD         
Sub-Investigator: Kohava Toledano, MD         
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Alexander Rozin, MD Rambam Health Care Campus and Technion
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Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01746966    
Other Study ID Numbers: 0260-10CTIL
First Posted: December 11, 2012    Key Record Dates
Last Update Posted: May 6, 2014
Last Verified: May 2014
Keywords provided by Rambam Health Care Campus:
gleno-humeral joint synovitis
anterior shoulder US
rotator interval
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases