View Clinical Trial (Medical Research Study)
A Prospective Comparison of Indirect and Direct MR Arthrography of the Shoulder Using Arthroscopic Correlation
| City: |
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Hershey |
| State: |
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Pennsylvania |
| Zip Code: |
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17033 |
| Conditions: |
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Shoulder Pain |
| Purpose: |
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This study will prospectively compare the findings of two diagnostic tests, Direct Magnetic
Resonance Arthrography(MRA) and Indirect MRA, to the findings during shoulder arthroscopy in
patients with shoulder pain. The sensitivity and specificity of both Direct and Indirect
MRA's in diagnosing specific pathologies of the shoulder will be determined using shoulder
arthroscopy as the gold standard.
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| Study Summary: |
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Direct MR arthrography (MRA) requires the injection of a contrast agent into the shoulder
under fluoroscopic or ultrasound guidance, followed by magnetic resonance imaging (MRI).
This is invasive, risks infection, and requires time and resources. It has recently been
shown that the intravenous administration of gadopentetate dimeglumine enhances the joint
cavity during an MRI and thus indirectly produces an arthrographic effect(Indirect MRA). The
study will enroll patients who have already had a Direct MRA as part of their standard of
care diagnostic test for shoulder pain, if it is determined by their surgeon that
arthroscopic surgery is indicated they will be asked if they would be willing to have an
Indirect MRA prior to their arthroscopic surgery. The patient will need to have a blood
test(BUN and Creatinine)done to ensure kidney function is normal, and a serum and urine
pregnancy test, if female, to ensure there is no pregnancy, prior to the completion of the
Indirect MRA. After the patient's scheduled shoulder arthroscopic surgery, the results of
the two MR arthrography techniques will be compared for sensitivity and specificity in
detecting partial and full thickness rotator cuff tears, labral tears, long head biceps
dislocation/tearing, and grade IV cartilage lesions by comparing the results to the actual
arthroscopic findings. The Direct MR arthrography and arthroscopic surgery are standard of
care and would occur regardless of this study, the Indirect MR arthrography is the
diagnostic intervention that is study-related.
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| Criteria: |
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Inclusion Criteria:
- Patients between 18 - 70 years old
- Continued shoulder pain for 2 months duration that limits his/her activity despite
conservative treatment
- Had a standard of care Direct MR arthrogram performed from which the surgeon
determined that arthroscopic surgery was indicated.
Exclusion Criteria:
Clinical Evidence of
- Tumor
- Infection
- Previous shoulder surgery
- Contraindication for MRI
- Allergy to contrast
- Coagulopathy
- Known allergy to gadolinium DTPA
- Renal failure with creatinine clearance of less than 30ml/min
- Pregnancy
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| NCT ID: |
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NCT01416740 |
| Primary Contact: |
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Principal Investigator
Robert Lyons, MD
Milton S. Hershey Medical Center
Pamela M Warlow, RN, BSN
Phone: 717-531-7127
Email: pwarlow@hmc.psu.edu
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| Backup Contact: |
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Email: rlyons@hmc.psu.edu
Robert Lyons, MD
Phone: 717-531-2771
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| Location Contact: |
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Hershey, Pennsylvania 17033
United States
Pamela M Warlow, RN, BSN
Phone: 717-531-7127
Email: pwarlow@hmc.psu.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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