Clinical trial NCT01416740: A Comparison of Indirect and Direct MR Arthrography of the Shoulder Using Arthroscopic Correlation
Official title: A Prospective Comparison of Indirect and Direct MR Arthrography of the Shoulder Using Arthroscopic Correlation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Shoulder Pain
Keywords: Indirect magnetic resonance arthrogram
Direct magnetic resonance arthrogram
Diagnostic tests for shoulder pain
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2011-08-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity and specificity of Direct and Indirect MR Arthrograms in detecting pathologies of the shoulder when compared with Arthroscopic findings.
timeFrame: Patients will be foollowed from their Indirect MRA to their arthoscopic shoulder surgery, approximately one month from time of consent
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Bone and Joint Institute, Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Robert Lyons, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jung JY, Yoon YC, Yi SK, Yoo J, Choe BK. Comparison study of indirect MR arthrography and direct MR arthrography of the shoulder. Skeletal Radiol. 2009 Jul;38(7):659-67. doi: 10.1007/s00256-009-0660-7. Epub 2009 Feb 19.
citation: Oh DK, Yoon YC, Kwon JW, Choi SH, Jung JY, Bae S, Yoo J. Comparison of indirect isotropic MR arthrography and conventional MR arthrography of labral lesions and rotator cuff tears: a prospective study. AJR Am J Roentgenol. 2009 Feb;192(2):473-9. doi: 10.2214/AJR.08.1223.
citation: Herold T, Bachthaler M, Hamer OW, Hente R, Feuerbach S, Fellner C, Strotzer M, Lenhart M, Paetzel C. Indirect MR arthrography of the shoulder: use of abduction and external rotation to detect full- and partial-thickness tears of the supraspinatus tendon. Radiology. 2006 Jul;240(1):152-60. doi: 10.1148/radiol.2393050453. Epub 2006 May 18.
citation: Dinauer PA, Flemming DJ, Murphy KP, Doukas WC. Diagnosis of superior labral lesions: comparison of noncontrast MRI with indirect MR arthrography in unexercised shoulders. Skeletal Radiol. 2007 Mar;36(3):195-202. doi: 10.1007/s00256-006-0237-7. Epub 2006 Dec 1.