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3T MRI Versus MR Arthrogram in SLAP Lesions

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ClinicalTrials.gov Identifier: NCT01896947
Recruitment Status : Withdrawn (Cost)
First Posted : July 11, 2013
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
Stephanie Muh, MD, Henry Ford Health System

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.

Condition or disease
Superior Labrum Anterior Posterior Lesion

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Three Tesla Magnetic Resonance Imaging Compared to Magnetic Resonance Arthrogram in Diagnosing Superior Labrum Anterior Posterior (SLAP) Lesions
Estimated Study Start Date : September 2013
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : January 2014

Group/Cohort
MRI and MRA group
All patients will receive 3T MRI and MR arthrogram



Primary Outcome Measures :
  1. Sensitivity 3T MRI [ Time Frame: 3 months ]
  2. Specificity 3T MRI [ Time Frame: 3 months ]
  3. Positive predictive value 3T MRI [ Time Frame: 3 months ]
  4. Negative predictive value 3T MRI [ Time Frame: 3 months ]
  5. Sensitivity MRA [ Time Frame: 3 months ]
  6. Specificity MRA [ Time Frame: 3 months ]
  7. Positive predictive value MRA [ Time Frame: 3 months ]
  8. Negative predictive value MRA [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • SLAP lesion

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01896947


Locations
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Investigators
Principal Investigator: Stephanie Muh, MD Henry Ford Hospital

Publications:

Responsible Party: Stephanie Muh, MD, Staff Physician, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT01896947     History of Changes
Other Study ID Numbers: SLAP MR study
First Posted: July 11, 2013    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018