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

NCT05691374 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2025-05-20

No results posted yet for this study

Summary

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.

Conditions

  • Arthroscopic Rotator Cuff Repair (ARCR)

Interventions

PROCEDURE

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)

PROCEDURE

Clinical examination

Clinical examination for shoulder range of motion and strength measurement

Sponsors & Collaborators

  • DePuy Synthes

    collaborator INDUSTRY

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Andreas Müller, Prof. Dr. med. · University Hospital Basel, Department of Orthopaedic and Trauma surgery

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-22
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05691374 on ClinicalTrials.gov