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

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.

Study Overview

• Status: Recruiting
• Conditions: Arthroscopic Rotator Cuff Repair (ARCR)
• Intervention / Treatment: Procedure: Ultrasound (US) examination; Procedure: Clinical examination

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.

• Study Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

• Study Contact: Name: Dominik M Bühler, Dr. med.; Phone Number: +41 61 556 59 69; Email: dominik.buehler@usb.ch
• Study Contact Backup: Name: Ilona Ahlborn; Phone Number: +41 79 753 37 24; Email: ilona.ahlborn@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • University Hospital Basel, Department of Orthopaedic and Trauma surgery
    • Contact: Ilona Ahlborn; Phone Number: +41 79 753 37 24; Email: ilona.ahlborn@usb.ch
    • Contact: Dominik Bühler, Dr. med.; Phone Number: +41 61 556 59 69; Email: dominik.buehler@usb.ch
    • Principal Investigator: Dominik Bühler, Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient selection from University Hospital Basel database

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shear wave propagation velocity in kPa	Elasticity of tendon and muscle (shear wave propagation velocity in kPa)	one time assessment (at least 2 years postoperatively)
Tendon integrity	Ultrasound of the repaired rotator cuff and biceps tendon (SSP, ISP, SSC, TM, long head of biceps)	one time assessment (at least 2 years postoperatively)
Fatty infiltration (SSP, ISP, SSC, TM)	Fatty infiltration of the repaired rotator cuff (SSP, ISP, SSC, TM) by ultrasound	one time assessment (at least 2 years postoperatively)
Diameter/Thickness of rotator cuff tendons (ISP, SSP, SSC, TM)	Diameter/Thickness of rotator cuff tendons (ISP, SSP, SSC, TM) by ultrasound	one time assessment (at least 2 years postoperatively)
Status of implants e.g. anchors	Status of implants e.g. anchors by ultrasound	one time assessment (at least 2 years postoperatively)
Suture cut-through (yes/no)	Suture cut-through (yes/no) by ultrasound	one time assessment (at least 2 years postoperatively)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Constant Murley Score (CMS)	The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.	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	Change in shoulder strength (kg) in 90° of abduction measured by handheld dynamometer	pre- operative, short-term (6 months postoperatively), and intermediate-term (at least 2 years) follow-up
Change in Patient-reported shoulder pain (NRS)	In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.	pre- operative, short-term (6 months postoperatively), and intermediate-term (at least 2 years) follow-up
Change in Patient-reported shoulder function (ASES)	The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is one pain scale worth 50 points and ten activities of daily living worth 50 points. The pain score is calculated by subtracting the visual analogue scale (VAS) from 10 and multiplying it by 5. The 10 functional questions are scored on a 4-point scale (0-3) with a maximum functional score of 30.	pre- operative, short-term (6 months postoperatively), and intermediate-term (at least 2 years) follow-up
Change in Subjective Shoulder Value (SSV)	The SSV score is defined as the subjective evaluation by the patient of shoulder function, expressed as a percentage of a normal shoulder. This score ranges from 0 to 100%.	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	The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.The scale is numbered from 0 to 100. 100 means the best health you can imagine. 0 means the worst health you can imagine.	pre- operative, short-term (6 months postoperatively), and intermediate-term (at least 2 years) follow-up

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: DePuy Synthes
• Investigators: Study Director: Andreas Müller, Prof. Dr. med., University Hospital Basel, Department of Orthopaedic and Trauma surgery

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2022
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: January 10, 2023
• First Submitted That Met QC Criteria: January 10, 2023
• First Posted (Actual): January 20, 2023

Study Record Updates

• Last Update Posted (Estimated): May 20, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: functional outcome; trapezius muscle; shear-wave elastography (SWE); rotator cuff muscle; biceps muscle; deltoid muscle; biomechanical outcome; biceps tendon; infraspinatus muscle (ISP); teres minor muscle (TM); subscapularis muscle (SSC); supraspinatus muscle (SSP)
• Other Study ID Numbers: 2022-02061; mu23Mueller

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No