3T MRI Versus MR Arthrogram in SLAP Lesions

NCT01896947 | Withdrawn DMC FDA Device

• 1 other identifier: SLAP MR study
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Superior Labrum Anterior Posterior Lesion

Outcome Measures

Primary Outcomes (8)

• Sensitivity 3T MRI

  3 months

• Specificity 3T MRI

  3 months

• Positive predictive value 3T MRI

  3 months

• Negative predictive value 3T MRI

  3 months

• Sensitivity MRA

  3 months

• Specificity MRA

  3 months

• Positive predictive value MRA

  3 months

• Negative predictive value MRA

  3 months

Study Arms (1)

MRI and MRA group

All patients will receive 3T MRI and MR arthrogram

Diagnostic Test: MRI

Interventions

MRI DIAGNOSTIC_TEST

evaluating to see if 3T MRI is as effective as MR arthrogram to diagnose labral pathology

MRI and MRA group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All skeletally mature patients with a suspected SLAP lesion on clinical exam will be eligible for the study.

You may qualify if:

• SLAP lesion

You may not qualify if:

• Skeletally immature
• Previous SLAP lesion on ipsilateral side
• Implants contraindicated for MRI

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Related Publications (8)

• 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.

  PMID: 18499376 BACKGROUND

• 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.

  PMID: 22938789 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

• 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. doi: 10.1177/03635465990270021601.

  PMID: 10102103 BACKGROUND

• 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. doi: 10.2214/ajr.182.5.1821271.

  PMID: 15100131 BACKGROUND

• 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. doi: 10.1016/j.arthro.2004.08.017.

  PMID: 15525929 BACKGROUND

• 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. doi: 10.1148/radiology.214.1.r00ja22267.

  PMID: 10644135 BACKGROUND

• 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. doi: 10.1148/radiology.218.1.r01ja44127.

  PMID: 11152790 BACKGROUND

Study Officials

• Stephanie Muh, MD

  Henry Ford Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: July 8, 2013
• First Posted: July 11, 2013
• Study Start: September 29, 2024
• Primary Completion: September 29, 2024
• Study Completion: September 29, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

US (1)