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

Not Applicable

Withdrawn

• Conditions: Shoulder Pain
• Interventions: Procedure: Indirect MRA of shoulder; Drug: Gadopentetate Dimeglumine

• Registration Number: NCT01416740
• Lead Sponsor: Milton S. Hershey Medical Center

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.

Study Timeline

• Study Start: 2009-12
• Status Verified: 2011-08
• Study First Submitted: 2011-08-11
• Study First Submitted QC: 2011-08-12
• Study First Posted: 2011-08-15
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Last Update Submitted: 2014-03-24
• Last Update Posted: 2014-03-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Indirect MRA	Indirect MRA of shoulder	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.
Indirect MRA	Gadopentetate Dimeglumine	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.

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of Direct and Indirect MR Arthrograms in detecting pathologies of the shoulder when compared with Arthroscopic findings.	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.

Trial Locations

Locations (1)

Bone and Joint Institute, Penn State Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States