3T MRI Versus MR Arthrogram in SLAP Lesions

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by Henry Ford Health System
Sponsor:
Information provided by (Responsible Party):
Stephanie Muh, MD, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT01896947
First received: July 8, 2013
Last updated: July 10, 2013
Last verified: July 2013
  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 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
Superior Labrum Anterior Posterior Lesion

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:
  • Sensitivity 3T MRI [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Specificity 3T MRI [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Positive predictive value 3T MRI [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Negative predictive value 3T MRI [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Sensitivity MRA [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Specificity MRA [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Positive predictive value MRA [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Negative predictive value MRA [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
MRI and MRA group
All patients will receive 3T MRI and MR arthrogram

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01896947

Contacts
Contact: Nickolas J Nahm, MD 815-685-0918 nnahm1@hfhs.org

Locations
United States, Michigan
Henry Ford Hospital Not yet recruiting
Detroit, Michigan, United States, 48202
Contact: Nickolas J Nahm, MD    815-685-0918    nnahm1@hfhs.org   
Principal Investigator: Stephanie Muh, MD         
Sub-Investigator: Courtney Scher, DO         
Sub-Investigator: Vasilios Moutzouros, MD         
Sub-Investigator: Hafeez Ahmed, MD         
Sub-Investigator: Nickolas Nahm, MD         
Sponsors and Collaborators
Henry Ford Health System
Investigators
Principal Investigator: Stephanie Muh, MD Henry Ford Hospital
  More Information

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
Study First Received: July 8, 2013
Last Updated: July 10, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 31, 2014