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3T MRI Versus MR Arthrogram in SLAP Lesions

NCT01896947 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2024-10-01

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

MRI

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

Sponsors & Collaborators

  • Henry Ford Health System

    lead OTHER

Principal Investigators

  • Stephanie Muh, MD · Henry Ford Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-29
Primary Completion
2024-09-29
Completion
2024-09-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01896947 on ClinicalTrials.gov