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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01896947




Registration number
NCT01896947
Ethics application status
Date submitted
8/07/2013
Date registered
11/07/2013
Date last updated
1/10/2024

Titles & IDs
Public title
3T MRI Versus MR Arthrogram in SLAP Lesions
Scientific title
Three Tesla Magnetic Resonance Imaging Compared to Magnetic Resonance Arthrogram in Diagnosing Superior Labrum Anterior Posterior (SLAP) Lesions
Secondary ID [1] 0 0
SLAP MR study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Superior Labrum Anterior Posterior Lesion 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - MRI

MRI and MRA group - All patients will receive 3T MRI and MR arthrogram


Diagnosis / Prognosis: MRI
evaluating to see if 3T MRI is as effective as MR arthrogram to diagnose labral pathology
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sensitivity 3T MRI
Timepoint [1] 0 0
3 months
Primary outcome [2] 0 0
Specificity 3T MRI
Timepoint [2] 0 0
3 months
Primary outcome [3] 0 0
Positive predictive value 3T MRI
Timepoint [3] 0 0
3 months
Primary outcome [4] 0 0
Negative predictive value 3T MRI
Timepoint [4] 0 0
3 months
Primary outcome [5] 0 0
Sensitivity MRA
Timepoint [5] 0 0
3 months
Primary outcome [6] 0 0
Specificity MRA
Timepoint [6] 0 0
3 months
Primary outcome [7] 0 0
Positive predictive value MRA
Timepoint [7] 0 0
3 months
Primary outcome [8] 0 0
Negative predictive value MRA
Timepoint [8] 0 0
3 months

Eligibility
Key inclusion criteria
* SLAP lesion
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Skeletally immature
* Previous SLAP lesion on ipsilateral side
* Implants contraindicated for MRI

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/09/2024
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Michigan

Funding & Sponsors
Primary sponsor type
Other
Name
Henry Ford Health System
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01896947
Trial related presentations / publications
Chang D, Mohana-Borges A, Borso M, Chung CB. SLAP lesions: anatomy, clinical presentation, MR imaging diagnosis and characterization. Eur J Radiol. 2008 Oct;68(1):72-87. doi: 10.1016/j.ejrad.2008.02.026. Epub 2008 May 21.
Phillips JC, Cook C, Beaty S, Kissenberth MJ, Siffri P, Hawkins RJ. Validity of noncontrast magnetic resonance imaging in diagnosing superior labrum anterior-posterior tears. J Shoulder Elbow Surg. 2013 Jan;22(1):3-8. doi: 10.1016/j.jse.2012.03.013. Epub 2012 Aug 29.
Dinauer PA, Flemming DJ, Murphy KP, Doukas WC. Diagnosis of superior labral lesions: comparison of noncontrast MRI with indirect MR arthrography in unexercised shoulders. Skeletal Radiol. 2007 Mar;36(3):195-202. doi: 10.1007/s00256-006-0237-7. Epub 2006 Dec 1.
Connell DA, Potter HG, Wickiewicz TL, Altchek DW, Warren RF. Noncontrast magnetic resonance imaging of superior labral lesions. 102 cases confirmed at arthroscopic surgery. Am J Sports Med. 1999 Mar-Apr;27(2):208-13. doi: 10.1177/03635465990270021601.
Waldt S, Burkart A, Lange P, Imhoff AB, Rummeny EJ, Woertler K. Diagnostic performance of MR arthrography in the assessment of superior labral anteroposterior lesions of the shoulder. AJR Am J Roentgenol. 2004 May;182(5):1271-8. doi: 10.2214/ajr.182.5.1821271.
Applegate GR, Hewitt M, Snyder SJ, Watson E, Kwak S, Resnick D. Chronic labral tears: value of magnetic resonance arthrography in evaluating the glenoid labrum and labral-bicipital complex. Arthroscopy. 2004 Nov;20(9):959-63. doi: 10.1016/j.arthro.2004.08.017.
Bencardino JT, Beltran J, Rosenberg ZS, Rokito A, Schmahmann S, Mota J, Mellado JM, Zuckerman J, Cuomo F, Rose D. Superior labrum anterior-posterior lesions: diagnosis with MR arthrography of the shoulder. Radiology. 2000 Jan;214(1):267-71. doi: 10.1148/radiology.214.1.r00ja22267.
Jee WH, McCauley TR, Katz LD, Matheny JM, Ruwe PA, Daigneault JP. Superior labral anterior posterior (SLAP) lesions of the glenoid labrum: reliability and accuracy of MR arthrography for diagnosis. Radiology. 2001 Jan;218(1):127-32. doi: 10.1148/radiology.218.1.r01ja44127.
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Stephanie Muh, MD
Address 0 0
Henry Ford Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01896947