Evaluation of Functional and Biomechanical Outcome by Shear-wave Elastography in the Short to Intermediate Follow-up After Arthroscopic Rotator Cuff Repair
NCT ID: NCT05691374
Last Updated: 2025-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
75 participants
OBSERVATIONAL
2022-12-22
2025-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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 continuity\|defect). Tissue elasticity measured by SWE in longitudinal orientation (in passive state and with active tension): Trapezius and Deltoid muscle: uninjured superficial muscle for individual patient muscle quality, SSP muscle and tendon: anterior and posterior part, SSC muscle and tendon: cranial and caudal part, ISP muscle and tendon, Biceps muscle and tendon: native (intraarticular) or subpectoral tenodesis (extraarticular)
Clinical examination
Clinical examination for shoulder range of motion and strength measurement
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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DePuy Synthes
INDUSTRY
University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Andreas Müller, Prof. Dr. med.
Role: STUDY_DIRECTOR
University Hospital Basel, Department of Orthopaedic and Trauma surgery
Locations
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University Hospital Basel, Department of Orthopaedic and Trauma surgery
Basel, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-02061; mu23Mueller
Identifier Type: -
Identifier Source: org_study_id
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