Kang 2009.
Clinical features and settings |
Inclusion criteria: Participants with clinical findings of impingement and suspected rotator cuff tear referred for MRA Exclusion criteria: Participants with previous rotator cuff repair, dislocation, previous humeral fracture, and infectious or inflammatory arthritis were excluded from the study Participants who showed clinical improvement while scheduled for surgery and refused it Duration of symptoms: Not reported Previous treatments: Not reported Care setting: Not reported |
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Participants |
Place of study: Seoul, Korea Period of study: February 2007 to August 2008 Number of participants eligible: 128 participants Number of participants enrolled IT and RS: ‐ MRA and arthroscopy: 50 participants ‐ 3D‐US and arthroscopy: 50 participants Data available for analyses: ‐ MRA and arthroscopy: 50 participants ‐ 3D‐US and arthroscopy: 50 participants Age: mean 55.6 years (range 22 to 78 years) Male/Female: 32/18 Dominant arm: Not reported Nature of onset: Not reported |
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Study design |
Primary objective: To compare the diagnostic performance of three‐dimensional (3D) US and MRA for both the detection of supraspinatus tendon tears and the quantification of their size, with arthroscopic findings used as the standard Study design: Prospective, consecutive, accuracy cohort study with fully paired direct comparison between MRA and 3D‐US Language: English |
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Target condition and reference standard(s) |
Target conditions: Presence of any rotator cuff tears, full thickness tears and partial thickness tears Reference standard(s): Shoulder arthroscopy ‐ Description of technique: In a partial thickness tear or in which the initial arthroscopic findings differed from those reported on the imaging, the rotator cuff was examined from both the articular side and the bursal side Cuff tear size was measured with a calibrated probe using the posterior portal to measure the anterior–posterior dimension and the lateral portal to measure the medial–lateral dimension ‐ Criteria for a positive result: The presence or absence of a full or partial thickness tear was noted at the arthroscopy An estimate of tear size was performed by the location of the medial edge of the tear |
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Index and comparator tests |
Index test(s): MRA and 3D‐US ‐ Description of technique: MRA MRI unit: 3.0 T magnet with a dedicated shoulder coil Sequences and Planes: Fat‐suppressed T1‐weighted spin‐echo images (TR/TE, 650 to 750/12) in the transverse plane, sagittal oblique plane and coronal oblique plane. T2‐weighted turbo spin‐echo (TSE) images (4000 to 4500/70) in the sagittal oblique and coronal oblique plane Contrast and procedure: 12 to 15 mL of diluted gadopentetate dimeglumine with a concentration of 2.0 mmol/L The procedure involved direct intra‐articular injection with fluoroscopic guidance Patient position: Supine with the arm in neutral position 3D US Scanner: 8 to 15 MHz with a dedicated 3D‐volume transducer Technique: Images were obtained in longitudinal scans of supraspinatus tendon 3D‐US data were transferred to a separate workstation which was equipped with various post‐processing software that allowed display and interactive analysis of the 3D data In the section mode the volume data were visualised in three orthogonal scan planes, i.e., longitudinal, transverse, and the C‐plane (parallel to the surface of the transducer) Patient position: Patients with the arm in internal rotation, as the patient placed his or her arm on the buttock ‐ Criteria for a positive result: MRA: Full‐thickness tears: the extension of the contrast medium through the entire thickness of the rotator cuff or presence of the contrast medium in the subacromial–subdeltoid bursa or both Partial thickness tears: no communication between the glenohumeral joint and the subacromial–subdeltoid bursa 3D‐US: Full thickness tear: a hypoechoic zone extending through the entire substance of the cuff or segmental or complete loss of rotator cuff substance with visualised tear margins or non‐visualisation of the cuff Partial thickness tear: a focal hypoechoic or anechoic defect in the tendon involving either the bursal or the articular surface and manifesting in both longitudinal transverse planes ‐ Time from symptoms to index test: Not reported ‐ Time from 3D‐US to MRA: The index tests were performed sequentially on the same day beginning with 3D‐US and ending with the MRA ‐ Time from index test to reference standard: mean 24.9 days (range 4 to 99 days |
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Follow‐up |
Adverse events due to index test(s): Not reported Adverse events due to reference standard test(s): Not reported |
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Notes | The rotator cuff tears were focused on only supraspinatus tendon tears A two‐by‐two table of the ITs and RS was given, which tallied with the reported summary data |
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Table of Methodological Quality | ||
Item | Authors' judgement | Description |
Representative spectrum? All tests | Unclear | Population was patients with suspected of having any rotator cuff tears The study was prospective and recruitment was consecutive The care setting was not specified |
Acceptable reference standard? All tests | Yes | The reference standard was arthroscopy and the target conditions were presence of full thickness tears and partial thickness tears |
Acceptable delay between tests? All tests | Yes | The average interval between reference standard and index test was less than one month |
Partial verification avoided? All tests | No | Not all the patients who received the index test underwent a reference standard to verify their true disease status Of the 128 eligible participants only 50 (39%) underwent to reference standard 16 patients (12.5%) refused surgery as they had improved and it was unclear why the other patients did not receive the reference standard |
Differential verification avoided? All tests | No | Probably the result of the index test influenced the choice of the reference standard |
Incorporation avoided? All tests | Yes | The index test did not form part of the reference standard |
Index test results blinded? All tests | Yes | The index tests were interpreted before and without knowledge of the reference standard results |
Reference standard results blinded? All tests | No | The results of the index tests were probably known to the person interpreting the reference tests |
Relevant clinical information? All tests | Unclear | Not reported |
Uninterpretable results reported? All tests | No | The results of 78 (41%) patients were not reported |
Withdrawals explained? All tests | No | Some of the eligible patients who entered the study did not complete it and these patients were not accounted for |
Learning curve / training reported of index test? All tests | Yes | The interpreter of MRA was a musculoskeletal radiologist with 15 years experience The interpreters of US were two radiologists with respectively 5 and 10 years experience performing musculoskeletal US |
Learning curve / training reported of reference standard? All tests | Unclear | Insufficient information was given to permit judgement |
Index test criteria for a positive test result reported? All tests | Yes | The study reported the definition of a positive index test result |