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Anterior Shoulder US - a New Access

This study is not yet open for participant recruitment.
Verified December 2012 by Rambam Health Care Campus
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01746966
First received: November 22, 2012
Last updated: December 9, 2012
Last verified: December 2012
History of Changes
  Purpose

  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
Rheumatoid Arthritis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Measurement of GHJ thickness and of rotator interval [ Time Frame: Six months ] [ Designated as safety issue: No ]

    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:
  • 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 ] [ Designated as safety issue: No ]
  • Data of comparison in measurement of rotator interval in patients with Rheumatoid Arthritis and controls. [ Time Frame: Eight months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: December 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01746966

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

Locations
Israel
Rheumatology unit Not yet 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
Principal Investigator: Alexander Rozin, MD Rambam Health Care Campus and Technion
  More Information

No publications provided

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01746966     History of Changes
Other Study ID Numbers: 0260-10CTIL
Study First Received: November 22, 2012
Last Updated: December 9, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:
gleno-humeral joint synovitis
anterior shoulder US
rotator interval

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013