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临床试验/NCT01896947
NCT01896947撤回不适用

Three Tesla Magnetic Resonance Imaging Compared to Magnetic Resonance Arthrogram in Diagnosing Superior Labrum Anterior Posterior (SLAP) Lesions

Henry Ford Health System1 个研究点 分布在 1 个国家开始时间: 2024年9月29日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Sensitivity 3T MRI

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • SLAP lesion

排除标准

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

结局指标

主要结局

Sensitivity 3T MRI

时间窗: 3 months

Negative predictive value 3T MRI

时间窗: 3 months

Sensitivity MRA

时间窗: 3 months

Positive predictive value MRA

时间窗: 3 months

Specificity 3T MRI

时间窗: 3 months

Specificity MRA

时间窗: 3 months

Positive predictive value 3T MRI

时间窗: 3 months

Negative predictive value MRA

时间窗: 3 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephanie Muh, MD

Staff Physician

Henry Ford Health System

研究点 (1)

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