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Sonoelastography to Predict Rotator Cuff Tears

1 mars 2021 uppdaterad av: Chang Gung Memorial Hospital

Use Sonoelastography to Predict the Reparability of Large-to-massive Rotator Cuff Tears

Large-to-massive rotator cuff tears accounts for 30% of all rotator cuff tears. These problems can be solved by surgeries, but only part of them can be completely repaired. The prognosis for partial repair is worse than complete repair, so evaluating the possibility of complete repair is so important that it will affect the decision of treatment. More and more recent researches focused on using magnetic resonance imaging (MRI) for evaluation of fatty infiltration of rotator cuff muscles to predict the reparability of large-to-massive rotator cuff tears. However, the availability of MRI is not that good as ultrasound, so some researchers are starting to use ultrasound to predict the reparability of large-to-massive rotator cuff tears. Because it is hard to observe the tissue quality through the general ultrasound, many researchers use sonoelastography to evaluate the tissue elasticity and viability. This aim of this study is to:

  1. check the reliability of sonoelastography.
  2. associate the findings of sonoelastography to the results of MRI.
  3. build a predictive model for the reparability of large-to-massive rotator cuff tears.

Studieöversikt

Status

Avslutad

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Faktisk)

50

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Kaohsiung, Taiwan, 833
        • Kaohsiung Chang Gung Memorial Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

The investigator will enroll participants with diagnosis of large-to-massive rotator cuff tears who will receive surgical repairs later, and sonoelastography and MRI are necessary for preoperative evaluation.

Beskrivning

Inclusion Criteria:

  1. Patients who are diagnosed with rotator cuff tear by an orthopedist.
  2. The large-to-massive rotator cuff tears need to be confirmed by magnetic resonance imaging or ultrasound. The definitions of this diagnosis include a tear over 3 cm or any full-thickness of tears in more than two rotator cuff muscles.
  3. Being willing to cooperated with the arranged examinations before the operation.

Exclusion Criteria:

  1. Patients who are only diagnosed with partial-thickness rotator cuff muscle tears or small- to large- sized full-thickness tears.
  2. Patients who have acromioclavicular arthritis that needs distal clavicle resection.
  3. Patients who had serious glenohumeral arthritis, pseudoparalysis, or any other shoulder trauma history.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Kohort
  • Tidsperspektiv: Tvärsnitt

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Sonoelastography
Tidsram: Baseline

This diagnostic test would be executed by a physician who has experiences of using Siemens Acuson S2000 ultrasound system for more than three year. The examination includes two of four rotator cuff muscles, listed as follows, supraspinatus muscle and infraspinatus muscle. Linear transducer (4-9 MHz) would be used for the whole test. The probe would be positioned along the longitudinal axis of the muscle belly.

Compressive sonoelastography technique is used for semiquantitative analysis. In order to maintain the quality of images, quality factor needs to be over or equal to 60. The quantitative analysis was performed by shear wave sonoelastography. While assessing, the region of interest (ROI) would be divided into four quadrants. The physicians will measure the shear wave velocity for wight times at the center point of each quadrant.

Baseline

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Passive range of motions
Tidsram: Baseline
Passive range of motions of internal and external rotation, abduction, extension, and flexion, which are assessed by a goniometer.
Baseline
Muscle strength
Tidsram: Baseline
Muscle strength assessment include the following motions, which are internal and external rotation, abduction, extension, and flexion. They are measured by a manual dynamometer.
Baseline
American Shoulder and Elbow Surgeons score.
Tidsram: Baseline
Shoulder function that are scaled by using American Shoulder and Elbow Surgeons score.
Baseline
MRI
Tidsram: Baseline
MRI was performed on a 1.5T system (Signa Horizon LX, GE Healthcare) equipped with a standard shoulder surface coil. The shoulder MRI protocol was identical for all patients and consisted of axial proton-density-weighted fast spin-echo with fat suppression sequence, the sequences was performed above the level o f the acromioclavicular joint down to below the axillary pouch with the following parameters: Coronal oblique proton-density-weighted with and without fat suppression, with axis parallel to the supraspinatus tendon, and sagittal oblique proton-density--weighted with and without fat suppression, with axis perpendicular to the coronal oblique axis, the ast spin-echo sequences were performed with the following parameters: TR msec/TE msec, 2700-4800 /25-40, echo-train length, 6; matrix, 256 × 256; field of view, 180 mm; section thickness, 2.5 mm with 2-mm gap. No IV or intraarticular gadolinium was administered.
Baseline
Surgical outcome
Tidsram: Baseline
The investigator will discuss the surgical outcome with the orthopedist to define whether the tear side is repaired partially or completely. If the tendon can be repaired using simple side-to-side tendon repair, horizontal mattress transosseous repair via the bone trough and reduced into an anatomic position, or via the rough area of greater tuberosity (marginal converging repair), it is defined as complete repair of the tendon. If the tendon cannot be reduced to the anatomic footprint and the orthopedist only secures re-attachment of the infraspinatus to the posterior side of greater tuberosity and/or the subscapularis of lesser tuberosity, it is defined as partial repair of the tendon.
Baseline
B-mode ultrasound
Tidsram: Baseline

The ultrasound machine will be calibrated similarly using the musculoskeletal (MSK) preset and B-mode with autogain. The dynamic range will be set at 70 dB for all participants. The examiners will apply adequate transducer pressure to obtain optimal images for comparisons of muscle and bone echo. The Heckmatt scale will be used to grade the muscle echogenicity within each ROI of supraspinatus and infraspinatus muscles. The grading rule is as follows:

  1. Grade 1: Normal
  2. Grade 2: Increased muscle echo intensity with distinct bone echo
  3. Grade 3: Marked increased muscle echo with reduced bone echo
  4. Grade 4: Very strong muscle echo and complete loss of bone echo
Baseline

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Studiestol: Po-Cheng Chen, MD, Chang Gung Memorial Hospital

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

22 oktober 2018

Primärt slutförande (Faktisk)

31 december 2020

Avslutad studie (Faktisk)

31 december 2020

Studieregistreringsdatum

Först inskickad

18 september 2018

Först inskickad som uppfyllde QC-kriterierna

21 september 2018

Första postat (Faktisk)

25 september 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 mars 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 mars 2021

Senast verifierad

1 februari 2020

Mer information

Termer relaterade till denna studie

Läkemedels- och apparatinformation, studiedokument

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produkt tillverkad i och exporterad från U.S.A.

Nej

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