Arthroscopic Rotator Cuff Repair (ARCR)NCT05691374
Evaluation of Functional and Biomechanical Outcome by Shear-wave Elastography in the Short to Intermediate Follow-up After Arthroscopic Rotator Cuff Repair
An observational study of Arthroscopic Rotator Cuff Repair (ARCR), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroscopic Rotator Cuff Repair (ARCR)
- What is being tested?
- Ultrasound (US) examination and Clinical examination
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Dec 2022to 19 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient selection from University Hospital Basel database
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Department of Orthopaedic and Trauma surgery
Basel, 4031
About this study
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.
Read the 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)
- Being tested
- Ultrasound (US) examination, Clinical examination
- Keywords
- shear-wave elastography (SWE), rotator cuff muscle, biceps muscle, deltoid muscle, trapezius muscle, functional outcome, biomechanical outcome, biceps tendon, infraspinatus muscle (ISP), teres minor muscle (TM), subscapularis muscle (SSC), supraspinatus muscle (SSP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound (US) examinationProcedure or surgery
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 examinationProcedure or surgery
Clinical examination for shoulder range of motion and strength measurement
What is being measured
The primary outcome is the main question the study is designed to answer.
Shear wave propagation velocity in kPa
Elasticity of tendon and muscle (shear wave propagation velocity in kPa)
Measured: 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)
Measured: 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
Measured: 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
Measured: one time assessment (at least 2 years postoperatively)
Status of implants e.g. anchors
Status of implants e.g. anchors by ultrasound
Measured: one time assessment (at least 2 years postoperatively)
Suture cut-through (yes/no)
Suture cut-through (yes/no) by ultrasound
Measured: one time assessment (at least 2 years postoperatively)
Secondary outcomes (6)
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.
Measured: 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
Measured: 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'.
Measured: 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.
Measured: 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%.
Measured: 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.
Measured: pre- operative, short-term (6 months postoperatively), and intermediate-term (at least 2 years) follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start22 Dec 2022
- Primary completion19 Aug 2025
- Study completion19 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroscopic Rotator Cuff Repair (ARCR)Studies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Synthes
- Responsible party
- Sponsor
- Investigators
- Andreas Müller, Prof. Dr. med., Study director, University Hospital Basel, Department of Orthopaedic and Trauma surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691374
- Sponsor's protocol ID
- 2022-02061; mu23Mueller
- Status last verified
- Aug 2026
- First submitted
- 10 Jan 2023
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Functional and Biomechanical Outcome by Shear-wave Elastography in the Short to Intermediate Follow-up After Arthroscopic Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT05691374
- Acronym / sponsor ID
- 2022-02061; mu23Mueller
- Conditions
- Arthroscopic Rotator Cuff Repair (ARCR)
- Keywords
- shear-wave elastography (SWE), rotator cuff muscle, biceps muscle, deltoid muscle, trapezius muscle, functional outcome, biomechanical outcome, biceps tendon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- DePuy Synthes
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 19 Aug 2025 (actual)
- Study completion
- 19 Aug 2025 (actual)
- First posted
- 20 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient selection from University Hospital Basel database
Key inclusion criteria (8 listed)
- year of surgery between 2015 and 2020
- ARCR surgery in cases of:
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound (US) examinationShear-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 or surgery | – |
| Clinical examinationClinical examination for shoulder range of motion and strength measurement | Procedure or surgery | – |
Primary outcome
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)
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)
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
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
Status of implants e.g. anchors
Time frame: one time assessment (at least 2 years postoperatively)
Status of implants e.g. anchors by ultrasound
Suture cut-through (yes/no)
Time frame: one time assessment (at least 2 years postoperatively)
Suture cut-through (yes/no) by ultrasound
6 secondary outcomes
Change in Constant Murley Score (CMS)
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
Time frame: pre- operative, short-term (6 months postoperatively), and intermediate-term (at least 2 years) follow-up
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
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
Change in Subjective Shoulder Value (SSV)
Time frame: 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
Time frame: pre- operative, short-term (6 months postoperatively), and intermediate-term (at least 2 years) follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Müller, Prof. Dr. med. study director
University Hospital Basel, Department of Orthopaedic and Trauma surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroscopic Rotator Cuff Repair (ARCR), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shear wave propagation velocity in kPa (time frame: one time assessment (at least 2 years postoperatively)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.