Evaluation of Functional and Biomechanical Outcome by Shear-wave Elastography in the Short to Intermediate Follow-up After Arthroscopic Rotator Cuff Repair

Обзор

This exploratory project will evaluate the biomechanical and functional intermediate-term outcome (2 to 5 years) after arthroscopic rotator cuff repair (ARCR) with modern non-invasive ultrasound techniques (especially shear wave elastography (SWE)), standardized physical examinations and patient-reported outcomes. It is to evaluate the biomechanical properties of tendons and muscles of the rotator cuff, as well as the biceps muscle after ARCR and to compare elasticity and structural properties to the healthy contralateral side.

Подробное описание

Arthroscopic repair of rotator cuff tears is commonly performed. However, recurrent tears after arthroscopic rotator cuff repair (ARCR) remain a significant clinical problem, especially in cases with large tears. Depending on literature, reported retear rates can range between 13% to 69%. Most likely, these tears reflect mechanical failure of the repair construct.

Ultrasound elastography is a recent technology and especially shear wave elastography (SWE) has experienced major developments in the past years. SWE offers an ultrasound based non-invasive quantitative tissue elasticity measurement by evaluating shear wave propagation speed which reflects the biomechanical properties of soft tissue. With this technique, the deltoid and trapezius muscle, several sections of the rotator cuff muscles and tendons as well as the proximal part of the long head of the biceps muscle can be evaluated. Results of the patient-reported outcomes and the physical examinations of the intermediate follow-up (2-5 years) will be compared with the data of the preoperative function.

It is a retrospective observational cohort study with additional prospective clinical data collection in terms of a physical examination and ultrasound examination.

There is no additional invasive procedure for this study.

Вмешательства

• Процедура Ultrasound (US) examination
  Shear-Wave Elastography (SWE) measurements of operated shoulder (quality, elasticity of repaired tendon) compared to healthy contralateral side. Parameters documented by regular US: Diameter of repaired tendon/ tendon thickness (mm), Rotator cuff muscle fatty infiltration (Grade 0-4), Signs of suture cut-through (yes \| no), Signs of anchor displacement and location (lateral\|medial row), Location of defect (at the foot print\|medial cuff failure), Status of long biceps tendon (intact\|in contin
• Процедура Clinical examination
  Clinical examination for shoulder range of motion and strength measurement

Первичные конечные точки

• Shear wave propagation velocity in kPa [Срок оценки: one time assessment (at least 2 years postoperatively)]
• Tendon integrity [Срок оценки: one time assessment (at least 2 years postoperatively)]
• Fatty infiltration (SSP, ISP, SSC, TM) [Срок оценки: one time assessment (at least 2 years postoperatively)]
• Diameter/Thickness of rotator cuff tendons (ISP, SSP, SSC, TM) [Срок оценки: one time assessment (at least 2 years postoperatively)]
• Status of implants e.g. anchors [Срок оценки: one time assessment (at least 2 years postoperatively)]
• Suture cut-through (yes/no) [Срок оценки: one time assessment (at least 2 years postoperatively)]

Вторичные конечные точки (6)

• Change in Constant Murley Score (CMS) [Срок оценки: pre- operative, short-term (6 months postoperatively), and intermediate-term (at least 2 years) follow-up]
• Change in shoulder strength (kg) in 90° of abduction measured by handheld dynamometer [Срок оценки: pre- operative, short-term (6 months postoperatively), and intermediate-term (at least 2 years) follow-up]
• Change in Patient-reported shoulder pain (NRS) [Срок оценки: pre- operative, short-term (6 months postoperatively), and intermediate-term (at least 2 years) follow-up]
• Change in Patient-reported shoulder function (ASES) [Срок оценки: pre- operative, short-term (6 months postoperatively), and intermediate-term (at least 2 years) follow-up]
• Change in Subjective Shoulder Value (SSV) [Срок оценки: pre- operative, short-term (6 months postoperatively), and intermediate-term (at least 2 years) follow-up]
• Change in Quality of life assessed by EQ-5D-5- questionnaire [Срок оценки: pre- operative, short-term (6 months postoperatively), and intermediate-term (at least 2 years) follow-up]

Критерии участия

Критерии включения

• year of surgery between 2015 and 2020
• ARCR surgery in cases of:

• Partial or complete supraspinatus (SSP) tear
• Partial or complete supraspinatus (ISP) tear
• Partial or complete subscapularis (SSC) tear
• Combined SSP, ISP and SSC tear
• with or without biceps tenodesis during same procedure
• able to understand the content of the patient information / consent form and give consent to take part in the study

Критерии исключения

• revision surgery (prior repair of the rotator cuff in the same shoulder)
• postoperative infections
• patients with a language barrier hindering questionnaire completion (either in German, French, Italian or English)
• legal incompetence
• not eligible for Ultrasound (BMI >35, persistent frozen shoulder)
• Prior surgery or injury of the contralateral shoulder

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Швейцария · 1 центр

• University Hospital Basel, Department of Orthopaedic and Trauma surgery — Basel

Идентификаторы

NCT: NCT05691374 · 2022-02061; mu23Mueller

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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