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
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.
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.
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