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NCT Number: NCT05691374

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.

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Key information

Conditions

Arthroscopic Rotator Cuff Repair (ARCR)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound (US) examination

Procedure

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

Procedure

Clinical examination for shoulder range of motion and strength measurement

Primary outcomes

  1. Shear wave propagation velocity in kPa

    Time frame: one time assessment (at least 2 years postoperatively)

    Elasticity of tendon and muscle (shear wave propagation velocity in kPa)

  2. Tendon integrity

    Time frame: one time assessment (at least 2 years postoperatively)

    Ultrasound of the repaired rotator cuff and biceps tendon (SSP, ISP, SSC, TM, long head of biceps)

  3. Fatty infiltration (SSP, ISP, SSC, TM)

    Time frame: one time assessment (at least 2 years postoperatively)

    Fatty infiltration of the repaired rotator cuff (SSP, ISP, SSC, TM) by ultrasound

  4. Diameter/Thickness of rotator cuff tendons (ISP, SSP, SSC, TM)

    Time frame: one time assessment (at least 2 years postoperatively)

    Diameter/Thickness of rotator cuff tendons (ISP, SSP, SSC, TM) by ultrasound

  5. Status of implants e.g. anchors

    Time frame: one time assessment (at least 2 years postoperatively)

    Status of implants e.g. anchors by ultrasound

  6. Suture cut-through (yes/no)

    Time frame: one time assessment (at least 2 years postoperatively)

    Suture cut-through (yes/no) by ultrasound

Secondary outcomes

  1. Change in Constant Murley Score (CMS)

    Time frame: pre- operative, short-term (6 months postoperatively), and intermediate-term (at least 2 years) follow-up

    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.

  2. Change in shoulder strength (kg) in 90° of abduction measured by handheld dynamometer

    Time frame: 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

  3. Change in Patient-reported shoulder pain (NRS)

    Time frame: pre- operative, short-term (6 months postoperatively), and intermediate-term (at least 2 years) follow-up

    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'.

  4. Change in Patient-reported shoulder function (ASES)

    Time frame: pre- operative, short-term (6 months postoperatively), and intermediate-term (at least 2 years) follow-up

    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.

  5. Change in Subjective Shoulder Value (SSV)

    Time frame: pre- operative, short-term (6 months postoperatively), and intermediate-term (at least 2 years) follow-up

    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%.

  6. Change in Quality of life assessed by EQ-5D-5- questionnaire

    Time frame: pre- operative, short-term (6 months postoperatively), and intermediate-term (at least 2 years) follow-up

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dominik M Bühler, Dr. med.

CONTACT

[email protected]

+41 61 556 59 69

Ilona Ahlborn

CONTACT

[email protected]

+41 79 753 37 24

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • DePuy Synthes

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 20, 2023
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.