3T MRI Versus MR Arthrogram in SLAP Lesions

Superior Labrum Anterior Posterior Lesion Clinical Trial

Official title:

Three Tesla Magnetic Resonance Imaging Compared to Magnetic Resonance Arthrogram in Diagnosing Superior Labrum Anterior Posterior (SLAP) Lesions

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01896947
• Other study ID #: SLAP MR study
• Status: Withdrawn
• Phase: N/A
• First received: July 8, 2013
• Last updated: February 21, 2018
• Start date: September 2013
• Est. completion date: January 2014

Study information

• Verified date: February 2018
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the diagnostic performance of three Tesla magnetic resonance imaging (3T MRI) compared to magnetic resonance arthrogram (MR arthrogram) in diagnosing superior labrum anterior posterior (SLAP) lesions. We hypothesize that 3T MRI will have non-inferior sensitivity compared to MR arthrogram in diagnosing SLAP lesions utilizing arthroscopy as our gold standard test. To evaluate our hypothesis, the investigators will include patients suspected to have a SLAP lesion on history and physical examination by a fellowship trained orthopaedic surgery. Patients will be offered advanced imaging (both 3T MRI and MR arthrogram) as well as arthroscopy for definitive diagnosis and treatment after consent is obtained. A fellowship trained musculoskeletal radiologist will perform and interpret the magnetic resonance tests while the arthroscopy will be performed by orthopaedic surgeons. The diagnostic characteristics of each imaging modality, including sensitivity, specificity, negative predictive value, and positive predictive value, will be compared to each other.

Description:

Purpose: The purpose of this study is to evaluate the diagnostic performance of three Tesla magnetic resonance imaging (3T MRI) compared to magnetic resonance arthrogram (MR arthrogram) in superior labrum anterior posterior (SLAP) lesions.

Specific aims: 1) Determine the diagnostic performance of 3T MRI in SLAP lesions utilizing arthroscopy as the gold standard (2) Determine the diagnostic performance of MR arthrogram in SLAP lesions utilizing arthroscopy as the gold standard (3) Compare the diagnostic performance of 3T MRI and MR arthrogram in SLAP lesions in a non-inferiority trial

Rationale: SLAP lesions are difficult to diagnose, even with advanced imaging (1). MRI and MR arthrogram are imaging modalities used to diagnose SLAP lesions while arthroscopy is the gold standard for diagnosing SLAP lesions. Recent study indicates that 1.5T MRI is not suitable for diagnosing SLAP lesions due to low specificity (2). The sensitivity and specificity of MRI have been reported between 66-98% and 75-91%, respectively (3,4). The reported sensitivity and specificity of MR arthrogram is generally higher at 82-100% and 58-98%, respectively (5-8). However, because the MR arthrogram is an invasive diagnostic tool, both MR arthrogram and MRI are considered standards of practice in the evaluation of SLAP lesions. To the investigators' knowledge, no previous study of SLAP lesions has evaluated the performance of 3T MRI, which has better diagnostic capabilities compared to 1.5T MRI, and compared it to MR arthrogram.

Significance: By comparing the performance of the 3T MRI and MR arthrogram in diagnosing SLAP lesions, the investigators will be able to make important diagnostic recommendations. For example, if 3T MRI is non-inferior to MR arthrogram, then the discomfort, potential harm of contrast agents, and extra resources required for MR arthrogram could be avoided with a 3T MRI.

Subjects: Inclusion criteria are patients suspected to have a SLAP lesion, either in isolation or in combination with other shoulder pathology, on history and physical examination by a fellowship trained shoulder and elbow surgeon or fellowship trained sports surgeon. Furthermore, patients must be indicated for arthroscopy. As part of standard of care, included patients will provide consent for arthroscopic evaluation. Exclusion criteria include skeletally immature patients, previously diagnosed SLAP lesion, previous intervention for SLAP lesion, contrast dye allergy, and implants that are contra-indicated for MRI.

Project design and protocol: All patients meeting inclusion and exclusion criteria will be evaluated prospectively. Patients eligible for participation will be identified in the clinics of two fellowship trained orthopaedic surgeons. The surgeons will obtain consent for study participation as well as shoulder arthroscopy. Patients will subsequently be referred to the Department of Radiology for 3T MRI and MR arthrogram. Consent for a shoulder MR arthrogram will be obtained and performed by a fellowship trained musculoskeletal radiologist. MRI and MR arthrogram images will be read by a fellowship trained musculoskeletal radiologist. Each patient will then undergo shoulder arthroscopy and indicated interventions by fellowship trained orthopaedic surgeons.

Data Analysis: Specific Aim 1: Sensitivity, specificity, negative predictive value, and positive predictive values will be calculated for MRI utilizing arthroscopy as the gold standard. These calculations will be made from a 2x2 Table. Specific Aim 2: Sensitivity, specificity, negative predictive value, and positive predictive values will be calculated for MR arthrography utilizing arthroscopy as the gold standard. These calculations will be made from a 2x2 Table. Specific Aim 3: Sensitivity, specificity, negative predictive value, and positive predictive values will be compared for 3T MRI and MR arthrogram. The investigators will evaluate for non-inferiority of 3T MRI to MR arthrogram Descriptive statistics for the cohort will be calculated with mean, median, and frequencies and distributions reported as appropriate.

Justification for number of subjects: Based on the reported sensitivity and specificity of MRI and MR arthrogram in the literature, the study is estimated to be adequately powered at 30 patients for a non-inferiority trial.

Tentative schedule for completing the project: The investigators estimate that approximately ten patients per month will be eligible for this study, based on the practice patterns of the orthopaedic surgeons involved in this study. An additonal month will be required for data analysis and writing the report.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• SLAP lesion

Exclusion Criteria:

• Skeletally immature

• Previous SLAP lesion on ipsilateral side

• Implants contraindicated for MRI

Related Conditions & MeSH terms

• Superior Labrum Anterior Posterior Lesion

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

References & Publications (8)

Applegate GR, Hewitt M, Snyder SJ, Watson E, Kwak S, Resnick D. Chronic labral tears: value of magnetic resonance arthrography in evaluating the glenoid labrum and labral-bicipital complex. Arthroscopy. 2004 Nov;20(9):959-63. — View Citation

Bencardino JT, Beltran J, Rosenberg ZS, Rokito A, Schmahmann S, Mota J, Mellado JM, Zuckerman J, Cuomo F, Rose D. Superior labrum anterior-posterior lesions: diagnosis with MR arthrography of the shoulder. Radiology. 2000 Jan;214(1):267-71. — View Citation

Chang D, Mohana-Borges A, Borso M, Chung CB. SLAP lesions: anatomy, clinical presentation, MR imaging diagnosis and characterization. Eur J Radiol. 2008 Oct;68(1):72-87. doi: 10.1016/j.ejrad.2008.02.026. Epub 2008 May 21. Review. — View Citation

Connell DA, Potter HG, Wickiewicz TL, Altchek DW, Warren RF. Noncontrast magnetic resonance imaging of superior labral lesions. 102 cases confirmed at arthroscopic surgery. Am J Sports Med. 1999 Mar-Apr;27(2):208-13. — View 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. Epub 2006 Dec 1. — View Citation

Jee WH, McCauley TR, Katz LD, Matheny JM, Ruwe PA, Daigneault JP. Superior labral anterior posterior (SLAP) lesions of the glenoid labrum: reliability and accuracy of MR arthrography for diagnosis. Radiology. 2001 Jan;218(1):127-32. — View Citation

Phillips JC, Cook C, Beaty S, Kissenberth MJ, Siffri P, Hawkins RJ. Validity of noncontrast magnetic resonance imaging in diagnosing superior labrum anterior-posterior tears. J Shoulder Elbow Surg. 2013 Jan;22(1):3-8. doi: 10.1016/j.jse.2012.03.013. Epub 2012 Aug 29. — View Citation

Waldt S, Burkart A, Lange P, Imhoff AB, Rummeny EJ, Woertler K. Diagnostic performance of MR arthrography in the assessment of superior labral anteroposterior lesions of the shoulder. AJR Am J Roentgenol. 2004 May;182(5):1271-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity 3T MRI		3 months
Primary	Specificity 3T MRI		3 months
Primary	Positive predictive value 3T MRI		3 months
Primary	Negative predictive value 3T MRI		3 months
Primary	Sensitivity MRA		3 months
Primary	Specificity MRA		3 months
Primary	Positive predictive value MRA		3 months
Primary	Negative predictive value MRA		3 months