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A Comparison of Indirect and Direct MR Arthrography of the Shoulder Using Arthroscopic Correlation

Primary Purpose

Shoulder Pain

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Indirect MRA of shoulder
Gadopentetate Dimeglumine
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Shoulder Pain focused on measuring Indirect magnetic resonance arthrogram, Direct magnetic resonance arthrogram, Diagnostic tests for shoulder pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bone and Joint Institute, Penn State Milton S. Hershey Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Indirect MRA

Arm Description

After patient has signed consent and had blood tests to ensure normal kidney function (BUN and Creatinine) as well as serum and urine pregnancy tests for females to ensure there is no pregnancy, the patient will have an Indirect MRA. The participant will be weighed and the correct dose of 0.1 mmol/kg calculated. An IV will be inserted into participant's arm. The gadopentetate dimeglumine will be injected into the IV and the patient will be asked to gently exercise the shoulder (small windmills and flexion/extension) for 5 minutes. The patients then undergo MRI imaging 15-30 minutes after the injection. Contraindications include known allergy to gadopentetate dimeglumine, and renal failure with creatinine clearance of less than 30ml/min.

Outcomes

Primary Outcome Measures

Sensitivity and specificity of Direct and Indirect MR Arthrograms in detecting pathologies of the shoulder when compared with Arthroscopic findings.
This study will compare the findings of the Indirect MRA and the retrospective data of the Direct MRA, to the results obtained during their arthroscopic shoulder surgery in patients with shoulder pain. The incidence of partial and full thickness rotator cuff tears, long head biceps dislocation/tearing, and grade IV cartilage lesions will be recorded for each type of MRA of the shoulder. The sensitivity and specificity of both direct and indirect MR arthrography in diagnosing shoulder problems will be determined by what was actually visualized during their arthroscopic shoulder surgery.

Secondary Outcome Measures

Full Information

First Posted
August 11, 2011
Last Updated
March 24, 2014
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01416740
Brief Title
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

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Withdrawn
Why Stopped
difficulty with recruitment, PI left the institution
Study Start Date
December 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
Indirect magnetic resonance arthrogram, Direct magnetic resonance arthrogram, Diagnostic tests for shoulder pain

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Indirect MRA
Arm Type
Experimental
Arm Description
After patient has signed consent and had blood tests to ensure normal kidney function (BUN and Creatinine) as well as serum and urine pregnancy tests for females to ensure there is no pregnancy, the patient will have an Indirect MRA. The participant will be weighed and the correct dose of 0.1 mmol/kg calculated. An IV will be inserted into participant's arm. The gadopentetate dimeglumine will be injected into the IV and the patient will be asked to gently exercise the shoulder (small windmills and flexion/extension) for 5 minutes. The patients then undergo MRI imaging 15-30 minutes after the injection. Contraindications include known allergy to gadopentetate dimeglumine, and renal failure with creatinine clearance of less than 30ml/min.
Intervention Type
Procedure
Intervention Name(s)
Indirect MRA of shoulder
Intervention Description
Patient will be weighed and the correct dose of 0.1 mmol/kg calculated. An IV will be inserted into patient's arm. The gadopentetate dimeglumine will be injected into the IV and the patient is asked to gently exercise the shoulder (small windmills and flexion/extension) for 5 minutes. The patients then undergo MRI imaging 15-30 minutes after the injection. Contraindications include known allergy to gadopentetate dimeglumine, and renal failure with creatinine clearance of less than 30ml/min.
Intervention Type
Drug
Intervention Name(s)
Gadopentetate Dimeglumine
Other Intervention Name(s)
gadolinium DTPA, Magnevist
Intervention Description
Patient will be weighed and the correct dose of 0.1 mmol/kg calculated. An IV will be inserted into patient's arm. The gadopentetate dimeglumine will be injected into the IV and the patient is asked to gently exercise the shoulder (small windmills and flexion/extension) for 5 minutes. The patients then undergo MRI imaging 15-30 minutes after the injection. Contraindications include known allergy to gadopentetate dimeglumine, and renal failure with creatinine clearance of less than 30ml/min.
Primary Outcome Measure Information:
Title
Sensitivity and specificity of Direct and Indirect MR Arthrograms in detecting pathologies of the shoulder when compared with Arthroscopic findings.
Description
This study will compare the findings of the Indirect MRA and the retrospective data of the Direct MRA, to the results obtained during their arthroscopic shoulder surgery in patients with shoulder pain. The incidence of partial and full thickness rotator cuff tears, long head biceps dislocation/tearing, and grade IV cartilage lesions will be recorded for each type of MRA of the shoulder. The sensitivity and specificity of both direct and indirect MR arthrography in diagnosing shoulder problems will be determined by what was actually visualized during their arthroscopic shoulder surgery.
Time Frame
Patients will be foollowed from their Indirect MRA to their arthoscopic shoulder surgery, approximately one month from time of consent

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Lyons, MD
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bone and Joint Institute, Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19225775
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.
Results Reference
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PubMed Identifier
19155413
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.
Results Reference
background
PubMed Identifier
16709790
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.
Results Reference
background
PubMed Identifier
17139503
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.
Results Reference
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A Comparison of Indirect and Direct MR Arthrography of the Shoulder Using Arthroscopic Correlation

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