NCT04819724|Completed

Load-induced Changes in Glenohumeral Translation in Patients With Rotator Cuff Tear

LiTrans

LiTrans - Influence of Additional Weight Carrying on Load-induced Changes in Glenohumeral Translation in Patients With Rotator Cuff Tear - a Translational Approach

University Hospital, Basel, Switzerland ClinicalTrials.gov

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1 other identifier

2021-00182; mu21Muendermann

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredMar 2021

StartedMay 2021

CompletionDec 2023

Brief 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. 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.7 years study duration

First Submitted

Initial submission to the registry

March 24, 2021

Completed

5 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed

1 month until next milestone

Study Start

First participant enrolled

May 4, 2021

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed

Last Updated

April 12, 2024

Status Verified

April 1, 2024

Enrollment Period

1.7 years

First QC Date

March 24, 2021

Last Update Submit

April 10, 2024

Conditions

Rotator Cuff Tear

Keywords

glenohumeral translationLoad-induced Glenohumeral Translation (liTr )Load-induced Muscle Activation (liMA)

Outcome Measures

Primary Outcomes (17)

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).
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.
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.
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%.
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)
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.
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)
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
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.
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
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.
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.
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.
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.
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).
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
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.
at baseline (approximate duration: 40 minutes).

Study Arms (3)

Group 1: patient group (unilateral rotator cuff tear)

OTHER

Group 1: 25 patients with unilateral symptomatic rotator cuff tear

Diagnostic Test: 3D motion analysisDiagnostic Test: isometric shoulder strength by dynamometerDiagnostic Test: fluoroscopic images of each shoulderDiagnostic 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)

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)

Interventions

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).