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

March 24, 2014 updated by: Milton S. Hershey Medical Center

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Bone and Joint Institute, Penn State Milton S. Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Indirect MRA
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.
Procedure: Indirect MRA of shoulder
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.
Drug: Gadopentetate Dimeglumine
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.
Other Names:
  • Magnevist
  • gadolinium DTPA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of Direct and Indirect MR Arthrograms in detecting pathologies of the shoulder when compared with Arthroscopic findings.
Time Frame: Patients will be foollowed from their Indirect MRA to their arthoscopic shoulder surgery, approximately one month from time of consent
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.
Patients will be foollowed from their Indirect MRA to their arthoscopic shoulder surgery, approximately one month from time of consent

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: Robert Lyons, MD, Milton S. Hershey Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

September 1, 2012

Study Registration Dates

First Submitted

August 11, 2011

First Submitted That Met QC Criteria

August 12, 2011

First Posted (ESTIMATE)

August 15, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 26, 2014

Last Update Submitted That Met QC Criteria

March 24, 2014

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31905

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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