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

NCT01416740 | Withdrawn

• 1 other identifier: 31905
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Pain

Keywords

Indirect magnetic resonance arthrogram; Direct magnetic resonance arthrogram; Diagnostic tests for shoulder pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Patients will be foollowed from their Indirect MRA to their arthoscopic shoulder surgery, approximately one month from time of consent

Study Arms (1)

Indirect MRA

EXPERIMENTAL

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; Drug: Gadopentetate Dimeglumine

Interventions

Indirect MRA of shoulder PROCEDURE

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.

Indirect MRA

Gadopentetate Dimeglumine DRUG

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.

Also known as: gadolinium DTPA, Magnevist

Indirect MRA

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

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

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (4)

• 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.

  PMID: 19225775 BACKGROUND

• 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.

  PMID: 19155413 BACKGROUND

• 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.

  PMID: 16709790 BACKGROUND

• 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.

  PMID: 17139503 BACKGROUND

MeSH Terms

Conditions

Shoulder Pain

Interventions

Gadolinium DTPA

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pentetic Acid; Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Coordination Complexes

Study Officials

• Robert Lyons, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 11, 2011
• First Posted: August 15, 2011
• Study Start: December 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: March 26, 2014

Record last verified: 2011-08

Locations

US (1)