NCT05691374

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 75 (estimated)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Arthroscopic Rotator Cuff Repair (ARCR)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-12-22
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2023-01-20
• Last updated: 2025-05-20

Locations

1 site across 1 country: Switzerland