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

This study has been withdrawn prior to enrollment.
(difficulty with recruitment, PI left the institution)
Sponsor:
Information provided by:
Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01416740
First received: August 11, 2011
Last updated: March 24, 2014
Last verified: August 2011
  Purpose

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.


Condition Intervention
Shoulder Pain
Procedure: Indirect MRA of shoulder
Drug: Gadopentetate Dimeglumine

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Prospective Comparison of Indirect and Direct MR Arthrography of the Shoulder Using Arthroscopic Correlation

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 0
Study Start Date: December 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • gadolinium DTPA
  • Magnevist

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01416740

Locations
United States, Pennsylvania
Bone and Joint Institute, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Principal Investigator: Robert Lyons, MD Milton S. Hershey Medical Center
  More Information

Publications:
Responsible Party: Robert Lyons M.D., Assistant Professor of Orthopaedic Surgery, Penn State Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01416740     History of Changes
Other Study ID Numbers: 31905
Study First Received: August 11, 2011
Last Updated: March 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Milton S. Hershey Medical Center:
Indirect magnetic resonance arthrogram
Direct magnetic resonance arthrogram
Diagnostic tests for shoulder pain

Additional relevant MeSH terms:
Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms
Gadolinium DTPA
Gadobenic acid
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014