Rotator Cuff TearLiTransNCT04819724
Load-induced Changes in Glenohumeral Translation in Patients With Rotator Cuff Tear
A study testing 3D motion analysis, isometric shoulder strength by dynamometer and fluoroscopic images of each shoulder in people with Rotator Cuff Tear, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The study is to investigate the dose-response relationship between load-induced muscle activation (liMA) and load-induced glenohumeral translation (liTr) in patients with rotator cuff tears and asymptomatic control subjects. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- 3D motion analysis, isometric shoulder strength by dynamometer and fluoroscopic images of each shoulder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 May 2021to 31 Dec 2023
- Phase
- Interventional
- 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 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed unilateral rotator cuff tear
- Partial or complete supraspinatus muscle tear
- With or without injury to other rotator cuff muscles
- No previous known elbow and shoulder injury or symptoms
Who cannot join
- Prior operative treatment of the ipsilateral shoulder or elbow
- Clinical history or symptoms of the contralateral glenohumeral joint
- Range of motion <30° in abduction and flexion
- Clinical history of the glenohumeral joint
- Prior conservative or operative treatment of the shoulder or elbow
- Range of motion <90° in abduction and flexion
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- General exclusion criteria:
- Inability to provide informed consent
- Body mass index (BMI) > 35 kg/m2 (Excessive skin movement)
- Neuromuscular disorders affecting upper limb movement
- Additional pathologies that influence the mobility of the shoulder joints
- Contraindications for MRI (e.g. neurostimulator and claustrophobia)
- Prior neuromuscular impairment (e.g. stroke)
- Diagnosed active rheumatic disorder
- Other major medical problems
- Pregnancy
- Patients currently enrolled in another experimental (interventional) protocol
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Orthopaedics and Traumatology, University Hospital Basel
Basel, 4031
About this study
Official title: LiTrans - Influence of Additional Weight Carrying on Load-induced Changes in Glenohumeral Translation in Patients With Rotator Cuff Tear - a Translational Approach
The study is to investigate the dose-response relationship between load-induced muscle activation (liMA) and load-induced glenohumeral translation (liTr) in patients with rotator cuff tears and asymptomatic control subjects.
Furthermore the study is to investigate the in vivo dose-response relationship between additional weight and glenohumeral translation, to understand the biological variation in liTr, the influence of disease pathology on the liTr, the potential compensation by muscle activation and muscle size, and the influence of liTr on patient outcomes.
Read the detailed description
This project is to test the overall hypothesis that rotator cuff tear affects glenohumeral translation and that this functional instability depends on additional load applied, on anatomical and morphological variations, and on type and severity of the injury. The study is to investigate the dose-response relationship between load-induced muscle activation (liMA) and load-induced glenohumeral translation (liTr) in patients with rotator cuff tears and asymptomatic control subjects.
Furthermore the study is to investigate the in vivo dose-response relationship between additional weight and glenohumeral translation, to understand the biological variation in liTr, the influence of disease pathology on the liTr, the potential compensation by muscle activation and muscle size, and the influence of liTr on patient outcomes.
This study entails cross-sectional experimental multimodal (clinical, biomechanical, radiological) data collection with multiple conditions and a control group.
- Conditions
- Rotator Cuff Tear
- Being tested
- 3D motion analysis, isometric shoulder strength by dynamometer, fluoroscopic images of each shoulder, Bilateral shoulder Magnetic Resonance Imaging (MRI), data collection by health questionnaires
- Keywords
- glenohumeral translation, Load-induced Glenohumeral Translation (liTr ), Load-induced Muscle Activation (liMA)
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D motion analysisDiagnostic test
30° arm abduction in the scapular plane will be performed with and without a handheld weight of 1, 2, 3, and 4 kg. All movements will be done bilaterally. Electromyographic (EMG) data of arm and trunk muscles will be recorded using surface electrodes. Participants will be asked to perform full arm abduction with different rotations (internal, neutral and external rotation), flexion and internal-/external rotations movements (without additional handheld weight).
isometric shoulder strength by dynamometerDiagnostic test
isometric shoulder strength for abduction and internal/external rotation will be assessed with a isometric shoulder strength for abduction and internal/external rotation will be assessed with a dynamometer
fluoroscopic images of each shoulderDiagnostic test
fluoroscopic images (Multitom Rax, Siemens Healthineers, Erlangen, Germany) of each shoulder will be taken during the 30° arm abduction test with and without a handheld weight (0, 2, and 4kg)
Bilateral shoulder Magnetic Resonance Imaging (MRI)Diagnostic test
MRI of both shoulders will be taken
data collection by health questionnairesOther
data collection by health questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Group 1: patient group (unilateral rotator cuff tear) | Other | Group 1: 25 patients with unilateral symptomatic rotator cuff tear Receives: Diagnostic Test: 3D motion analysis; Diagnostic Test: isometric shoulder strength by dynamometer; Diagnostic Test: fluoroscopic images of each shoulder; Diagnostic Test: Bilateral shoulder Magnetic Resonance Imaging (MRI); Other: data collection by health questionnaires |
| Group 2: control group (asymptomatic volunteers) | Other | Group 2: (asymptomatic volunteers) 25 asymptomatic control subjects (age and sex distribution matching the patient group) Receives: Diagnostic Test: 3D motion analysis; Diagnostic Test: isometric shoulder strength by dynamometer; Diagnostic Test: fluoroscopic images of each shoulder; Diagnostic Test: Bilateral shoulder Magnetic Resonance Imaging (MRI); Other: data collection by health questionnaires |
| Group 2: young control group (young asymptomatic volunteers) | Other | Group 3: (young asymptomatic volunteers) 25 asymptomatic control subjects, 20 to 30 years (sex distribution matching the patient group) Receives: Diagnostic Test: 3D motion analysis; Diagnostic Test: isometric shoulder strength by dynamometer; Diagnostic Test: fluoroscopic images of each shoulder; Diagnostic Test: Bilateral shoulder Magnetic Resonance Imaging (MRI); Other: data collection by health questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of arm, shoulder and hand (Quick DASH) questionnaire
30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale (1 being no difficulty, 5 being unable).
Measured: at baseline (approximate duration for all questionnaires: 20 minutes)
Constant Score
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. 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: at baseline (approximate duration for all questionnaires: 20 minutes)
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
The American Shoulder and Elbow Surgeons Shoulder Score (ASES) is a mixed outcome reporting measure, applicable for use in all patients with shoulder pathology regardless of their specific diagnosis. The ASES questionnaire is composed of both a physician-rated component and a patient-reported component. The patient questions focus on joint pain, instability, and activities of daily living. The pain and functional portions are summed to obtain the final ASES score with higher scores indicating better outcomes.
Measured: at baseline (approximate duration for all questionnaires: 20 minutes)
Subjective Shoulder Value (SSV)
The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%.
Measured: at baseline (approximate duration for all questionnaires: 20 minutes)
numerical pain rating scale (NRS) score
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults (from 0-10: "0" = no pain. "10" = the most intense pain imaginable)
Measured: at baseline (approximate duration for all questionnaires: 20 minutes)
Loaded shoulder abduction test with motion analysis
The subject will lift their arm to 30° shoulder abduction in the scapular plane, data will be captured holding 0, 1, 2, 3, and 4 kg, respectively, in their hand. Reflective surface markers will be placed bilaterally on the participants' trunk and arms. Position of these markers will be recorded using infrared cameras that only record the reflections of the markers. Additionally, inertial sensors will be positioned on the subjects' thorax, scapulae, humeri and forearms.
Measured: at baseline (approximate duration for motion analysis: 50 minutes)
Loaded shoulder abduction test with single plane fluoroscopic images
fluoroscopic images (Multitom Rax, Siemens Healthineers, Erlangen, Germany) of each shoulder will be taken during the 30° arm abduction test with and without a handheld weight (0, 2, and 4kg)
Measured: at baseline (approximate duration for motion analysis: 50 minutes).
Load-induced muscle activity from electromyography (EMG)
During arm movements in the loaded shoulder test and muscle strength tests, muscle activation of the infraspinatus, biceps brachii, anterior, middle and posterior part of the deltoid, clavicular part of the pectoralis major, latissimus dorsi and the upper part of the trapezius will be measured bilaterally using a 16-channel EMG system
Measured: at baseline (approximate duration for motion analysis: 50 minutes)
Glenohumeral translation from single plane fluoroscopy
the vertical distance of the glenohumeral joint centre (GHJC) and the radiopaque acromion marker will be measured. Fluoroscopy (FL) based liTr will be calculated for each participant as the slope of the regression of the negative GHJC to acromion distance measurements on the load magnitude.
Measured: at baseline (approximate duration for motion analysis: 50 minutes)
Glenohumeral translation from instrumented motion analysis
The vertical distance of the GHJC to the acromion marker will be calculated for a neutral trial and with the arm in 30° shoulder abduction for each loading condition. Motion analysis (MA) based liTr will be calculated for each participant as the slope of the regression of the negative GHJC to acromion distance measurements on the load magnitude
Measured: at baseline (approximate duration for motion analysis: 50 minutes)
Critical shoulder angle (CSA)
Subject's CSA will be measured on an anterior-posterior double-obliquity fluoroscopy image of the shoulder as the angle subtended by a line parallel to the glenoid and a line through the inferior-lateral edge of the glenoid and the inferior-lateral edge of the acromion. The CSA is reproducible and significantly greater in patients with rotator cuff tears than the general population. High angles (>35°-38°) have been associated with rotator cuff tears and greater joint instability.
Measured: at baseline (approximate duration for motion analysis: 50 minutes)
Glenoid inclination (GI)
GI will be measured on the fluoroscopy image as the angle between a line from the upper to the lower glenoid rim (glenoid plane) and a second line set on the floor of the supraspinous fossa. Abnormal GI might be associated with rotator cuff tears and superior humeral head migration.
Measured: at baseline (approximate duration for motion analysis: 50 minutes)
Greater tuberosity angle (GTA)
GTA will be measured as the angle between a line parallel to the humerus diaphysis through the GHJC and a line from the upper border of the humeral head to the most superolateral edge of the greater tuberosity. A GTA of more than 70° has been observed to predict rotator cuff tear.
Measured: at baseline (approximate duration for motion analysis: 50 minutes)
Muscle cross sectional area (MCSA)
The MCSA of all rotator cuff muscles will be measured at two different positions on parasagittal reformatted images. MCSA of the deltoid will also be measured on the axial plane at the middle of the glenoid.
Measured: at baseline (approximate duration is approximately 1 hour and 15 minutes)
Tear size retrieved from MR images
Tear size will be classified into partial (1) or complete supraspinatus muscle tear (2).
Measured: at baseline (approximate duration is approximately 1 hour and 15 minutes)
Tear type retrieved from MR images
Tear type will be classified into supraspinatus tear without injury to other rotator cuff muscles (type A) and with injury to other rotator cuff muscles (type B). Both will be used as indicators for injury severity
Measured: at baseline (approximate duration is approximately 1 hour and 15 minutes)
Isometric shoulder muscle strength for abduction and internal/external rotation
Shoulder muscle strength will be tested under isometric conditions using a dynamometer. The maximum of 3 trials will be calculated and recorded as the participant's maximum isometric strength.
Measured: at baseline (approximate duration: 40 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start4 May 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- cross-sectional experimental multimodal (clinical, biomechanical, radiological) data collection with multiple conditions and a control group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Sponsor
- Investigators
- Annegret Mündermann, Prof. Dr., Principal investigator, Department of Orthopaedics and Traumatology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04819724
- Sponsor's protocol ID
- 2021-00182; mu21Muendermann
- Acronym
- LiTrans
- Status last verified
- Apr 2024
- First submitted
- 24 Mar 2021
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Croci E, Hess H, Genter J, Baum C, Kovacs BK, Nuesch C, Baumgartner D, Gerber K, Muller AM, Mundermann A. Severity of rotator cuff disorders and additional load affect fluoroscopy-based shoulder kinematics during arm abduction. J Orthop Traumatol. 2024 Jun 8;25(1):30. doi: 10.1186/s10195-024-00774-2.
PubMed 38850466Croci E, Warmuth F, Baum C, Kovacs BK, Nuesch C, Baumgartner D, Muller AM, Mundermann A. Load-induced increase in muscle activity during 30 degrees abduction in patients with rotator cuff tears and control subjects. J Orthop Traumatol. 2023 Aug 4;24(1):41. doi: 10.1186/s10195-023-00720-8.
PubMed 37542140Croci E, Eckers F, Nuesch C, Aghlmandi S, Kovacs BK, Genter J, Baumgartner D, Muller AM, Mundermann A. Load-Induced Glenohumeral Translation After Rotator Cuff Tears: Protocol for an In Vivo Study. JMIR Res Protoc. 2022 Dec 23;11(12):e43769. doi: 10.2196/43769.
PubMed 36563028
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LiTrans - Influence of Additional Weight Carrying on Load-induced Changes in Glenohumeral Translation in Patients With Rotator Cuff Tear - a Translational Approach
- ClinicalTrials.gov ID
- NCT04819724
- Acronym / sponsor ID
- LiTrans / 2021-00182; mu21Muendermann
- Conditions
- Rotator Cuff Tear
- Keywords
- glenohumeral translation, Load-induced Glenohumeral Translation (liTr ), Load-induced Muscle Activation (liMA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- 4 May 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 29 Mar 2021 (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.
The study is to investigate the dose-response relationship between load-induced muscle activation (liMA) and load-induced glenohumeral translation (liTr) in patients with rotator cuff tears and asymptomatic control subjects.
Furthermore the study is to investigate the in vivo dose-response relationship between additional weight and glenohumeral translation, to understand the biological variation in liTr, the influence of disease pathology on the liTr, the potential compensation by muscle activation and muscle size, and the influence of liTr on patient outcomes.
Detailed description
This project is to test the overall hypothesis that rotator cuff tear affects glenohumeral translation and that this functional instability depends on additional load applied, on anatomical and morphological variations, and on type and severity of the injury. The study is to investigate the dose-response relationship between load-induced muscle activation (liMA) and load-induced glenohumeral translation (liTr) in patients with rotator cuff tears and asymptomatic control subjects.
Furthermore the study is to investigate the in vivo dose-response relationship between additional weight and glenohumeral translation, to understand the biological variation in liTr, the influence of disease pathology on the liTr, the potential compensation by muscle activation and muscle size, and the influence of liTr on patient outcomes.
This study entails cross-sectional experimental multimodal (clinical, biomechanical, radiological) data collection with multiple conditions and a control group.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- cross-sectional experimental multimodal (clinical, biomechanical, radiological) data collection with multiple conditions and a control group
| Arm | Type | Receives |
|---|---|---|
| Group 1: patient group (unilateral rotator cuff tear) | Other | Diagnostic Test: 3D motion analysis, Diagnostic Test: isometric shoulder strength by dynamometer, Diagnostic Test: fluoroscopic images of each shoulder, Diagnostic Test: Bilateral shoulder Magnetic Resonance Imaging (MRI), Other: data collection by health questionnairesGroup 1: 25 patients with unilateral symptomatic rotator cuff tear |
| Group 2: control group (asymptomatic volunteers) | Other | Diagnostic Test: 3D motion analysis, Diagnostic Test: isometric shoulder strength by dynamometer, Diagnostic Test: fluoroscopic images of each shoulder, Diagnostic Test: Bilateral shoulder Magnetic Resonance Imaging (MRI), Other: data collection by health questionnairesGroup 2: (asymptomatic volunteers) 25 asymptomatic control subjects (age and sex distribution matching the patient group) |
| Group 2: young control group (young asymptomatic volunteers) | Other | Diagnostic Test: 3D motion analysis, Diagnostic Test: isometric shoulder strength by dynamometer, Diagnostic Test: fluoroscopic images of each shoulder, Diagnostic Test: Bilateral shoulder Magnetic Resonance Imaging (MRI), Other: data collection by health questionnairesGroup 3: (young asymptomatic volunteers) 25 asymptomatic control subjects, 20 to 30 years (sex distribution matching the patient group) |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed unilateral rotator cuff tear
- Partial or complete supraspinatus muscle tear
- With or without injury to other rotator cuff muscles
- No previous known elbow and shoulder injury or symptoms
Key exclusion criteria (17 listed)
- Prior operative treatment of the ipsilateral shoulder or elbow
- Clinical history or symptoms of the contralateral glenohumeral joint
- Range of motion <30° in abduction and flexion
- Clinical history of the glenohumeral joint
- Prior conservative or operative treatment of the shoulder or elbow
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 |
|---|---|---|
| 3D motion analysis30° arm abduction in the scapular plane will be performed with and without a handheld weight of 1, 2, 3, and 4 kg. All movements will be done bilaterally. Electromyographic (EMG) data of arm and trunk muscles will be recorded using surface electrodes. Participants will be asked to perform full arm abduction with different rotations (internal, neutral and external rotation), flexion and internal-/external rotations movements (without additional handheld weight). | Diagnostic test | Group 1: patient group (unilateral rotator cuff tear), Group 2: control group (asymptomatic volunteers), Group 2: young control group (young asymptomatic volunteers) |
| isometric shoulder strength by dynamometerisometric shoulder strength for abduction and internal/external rotation will be assessed with a isometric shoulder strength for abduction and internal/external rotation will be assessed with a dynamometer | Diagnostic test | Group 1: patient group (unilateral rotator cuff tear), Group 2: control group (asymptomatic volunteers), Group 2: young control group (young asymptomatic volunteers) |
| fluoroscopic images of each shoulderfluoroscopic images (Multitom Rax, Siemens Healthineers, Erlangen, Germany) of each shoulder will be taken during the 30° arm abduction test with and without a handheld weight (0, 2, and 4kg) | Diagnostic test | Group 1: patient group (unilateral rotator cuff tear), Group 2: control group (asymptomatic volunteers), Group 2: young control group (young asymptomatic volunteers) |
| Bilateral shoulder Magnetic Resonance Imaging (MRI)MRI of both shoulders will be taken | Diagnostic test | Group 1: patient group (unilateral rotator cuff tear), Group 2: control group (asymptomatic volunteers), Group 2: young control group (young asymptomatic volunteers) |
| data collection by health questionnairesdata collection by health questionnaires | Other | Group 1: patient group (unilateral rotator cuff tear), Group 2: control group (asymptomatic volunteers), Group 2: young control group (young asymptomatic volunteers) |
Primary outcome
Disabilities of arm, shoulder and hand (Quick DASH) questionnaire
Time frame: at baseline (approximate duration for all questionnaires: 20 minutes)
30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale (1 being no difficulty, 5 being unable).
Constant Score
Time frame: at baseline (approximate duration for all questionnaires: 20 minutes)
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. 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.
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Time frame: at baseline (approximate duration for all questionnaires: 20 minutes)
The American Shoulder and Elbow Surgeons Shoulder Score (ASES) is a mixed outcome reporting measure, applicable for use in all patients with shoulder pathology regardless of their specific diagnosis. The ASES questionnaire is composed of both a physician-rated component and a patient-reported component. The patient questions focus on joint pain, instability, and activities of daily living. The pain and functional portions are summed to obtain the final ASES score with higher scores indicating better outcomes.
Subjective Shoulder Value (SSV)
Time frame: at baseline (approximate duration for all questionnaires: 20 minutes)
The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%.
numerical pain rating scale (NRS) score
Time frame: at baseline (approximate duration for all questionnaires: 20 minutes)
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults (from 0-10: "0" = no pain. "10" = the most intense pain imaginable)
Loaded shoulder abduction test with motion analysis
Time frame: at baseline (approximate duration for motion analysis: 50 minutes)
The subject will lift their arm to 30° shoulder abduction in the scapular plane, data will be captured holding 0, 1, 2, 3, and 4 kg, respectively, in their hand. Reflective surface markers will be placed bilaterally on the participants' trunk and arms. Position of these markers will be recorded using infrared cameras that only record the reflections of the markers. Additionally, inertial sensors will be positioned on the subjects' thorax, scapulae, humeri and forearms.
Loaded shoulder abduction test with single plane fluoroscopic images
Time frame: at baseline (approximate duration for motion analysis: 50 minutes).
fluoroscopic images (Multitom Rax, Siemens Healthineers, Erlangen, Germany) of each shoulder will be taken during the 30° arm abduction test with and without a handheld weight (0, 2, and 4kg)
Load-induced muscle activity from electromyography (EMG)
Time frame: at baseline (approximate duration for motion analysis: 50 minutes)
During arm movements in the loaded shoulder test and muscle strength tests, muscle activation of the infraspinatus, biceps brachii, anterior, middle and posterior part of the deltoid, clavicular part of the pectoralis major, latissimus dorsi and the upper part of the trapezius will be measured bilaterally using a 16-channel EMG system
Glenohumeral translation from single plane fluoroscopy
Time frame: at baseline (approximate duration for motion analysis: 50 minutes)
the vertical distance of the glenohumeral joint centre (GHJC) and the radiopaque acromion marker will be measured. Fluoroscopy (FL) based liTr will be calculated for each participant as the slope of the regression of the negative GHJC to acromion distance measurements on the load magnitude.
Glenohumeral translation from instrumented motion analysis
Time frame: at baseline (approximate duration for motion analysis: 50 minutes)
The vertical distance of the GHJC to the acromion marker will be calculated for a neutral trial and with the arm in 30° shoulder abduction for each loading condition. Motion analysis (MA) based liTr will be calculated for each participant as the slope of the regression of the negative GHJC to acromion distance measurements on the load magnitude
Critical shoulder angle (CSA)
Time frame: at baseline (approximate duration for motion analysis: 50 minutes)
Subject's CSA will be measured on an anterior-posterior double-obliquity fluoroscopy image of the shoulder as the angle subtended by a line parallel to the glenoid and a line through the inferior-lateral edge of the glenoid and the inferior-lateral edge of the acromion. The CSA is reproducible and significantly greater in patients with rotator cuff tears than the general population. High angles (>35°-38°) have been associated with rotator cuff tears and greater joint instability.
Glenoid inclination (GI)
Time frame: at baseline (approximate duration for motion analysis: 50 minutes)
GI will be measured on the fluoroscopy image as the angle between a line from the upper to the lower glenoid rim (glenoid plane) and a second line set on the floor of the supraspinous fossa. Abnormal GI might be associated with rotator cuff tears and superior humeral head migration.
Greater tuberosity angle (GTA)
Time frame: at baseline (approximate duration for motion analysis: 50 minutes)
GTA will be measured as the angle between a line parallel to the humerus diaphysis through the GHJC and a line from the upper border of the humeral head to the most superolateral edge of the greater tuberosity. A GTA of more than 70° has been observed to predict rotator cuff tear.
Muscle cross sectional area (MCSA)
Time frame: at baseline (approximate duration is approximately 1 hour and 15 minutes)
The MCSA of all rotator cuff muscles will be measured at two different positions on parasagittal reformatted images. MCSA of the deltoid will also be measured on the axial plane at the middle of the glenoid.
Tear size retrieved from MR images
Time frame: at baseline (approximate duration is approximately 1 hour and 15 minutes)
Tear size will be classified into partial (1) or complete supraspinatus muscle tear (2).
Tear type retrieved from MR images
Time frame: at baseline (approximate duration is approximately 1 hour and 15 minutes)
Tear type will be classified into supraspinatus tear without injury to other rotator cuff muscles (type A) and with injury to other rotator cuff muscles (type B). Both will be used as indicators for injury severity
Isometric shoulder muscle strength for abduction and internal/external rotation
Time frame: at baseline (approximate duration: 40 minutes).
Shoulder muscle strength will be tested under isometric conditions using a dynamometer. The maximum of 3 trials will be calculated and recorded as the participant's maximum isometric strength.
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 12 Apr 2024.
- Derived from this study: PubMed 38850466Croci E, Hess H, Genter J, Baum C, Kovacs BK, Nuesch C, Baumgartner D, Gerber K, Muller AM, Mundermann A. Severity of rotator cuff disorders and additional load affect fluoroscopy-based shoulder kinematics during arm abduction. J Orthop Traumatol. 2024 Jun 8;25(1):30. doi: 10.1186/s10195-024-00774-2.
- Derived from this study: PubMed 37542140Croci E, Warmuth F, Baum C, Kovacs BK, Nuesch C, Baumgartner D, Muller AM, Mundermann A. Load-induced increase in muscle activity during 30 degrees abduction in patients with rotator cuff tears and control subjects. J Orthop Traumatol. 2023 Aug 4;24(1):41. doi: 10.1186/s10195-023-00720-8.
- Derived from this study: PubMed 36563028Croci E, Eckers F, Nuesch C, Aghlmandi S, Kovacs BK, Genter J, Baumgartner D, Muller AM, Mundermann A. Load-Induced Glenohumeral Translation After Rotator Cuff Tears: Protocol for an In Vivo Study. JMIR Res Protoc. 2022 Dec 23;11(12):e43769. doi: 10.2196/43769.
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Arthroplasty, Replacement
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.
Annegret Mündermann, Prof. Dr. principal investigator
Department of Orthopaedics and Traumatology, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D motion analysis, isometric shoulder strength by dynamometer and fluoroscopic images of each shoulder in people with Rotator Cuff Tear, 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 4 inclusion and 17 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 12 Apr 2024. 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?
Disabilities of arm, shoulder and hand (Quick DASH) questionnaire (time frame: at baseline (approximate duration for all questionnaires: 20 minutes)). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04819724, which also lists 3 linked publications.
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 12 Apr 2024.