Clinical trial NCT04819724: Load-induced Changes in Glenohumeral Translation in Patients With Rotator Cuff Tear
Official title: LiTrans - Influence of Additional Weight Carrying on Load-induced Changes in Glenohumeral Translation in Patients With Rotator Cuff Tear - a Translational Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tear
Keywords: glenohumeral translation
Load-induced Glenohumeral Translation (liTr )
Load-induced Muscle Activation (liMA)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2021-03-29
Enrollment: 75
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cross-sectional experimental multimodal (clinical, biomechanical, radiological) data collection with multiple conditions and a control group
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: We will examine a cohort of 75 subjects:

* Group 1: 25 patients with unilateral symptomatic rotator cuff tear between 45 and 85 years
* Group 2: 25 asymptomatic control subjects (age and sex distribution matching the patient group) Group 3: 25 sex matched young asymptomatic control subjects between 20 and 30 years

Inclusion criteria patients:

* Diagnosed unilateral rotator cuff tear
* Partial or complete supraspinatus muscle tear
* With or without injury to other rotator cuff muscles

Exclusion criteria patients:

* 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

Inclusion criteria asymptomatic control subjects:

- No previous known elbow and shoulder injury or symptoms

Exclusion criteria asymptomatic control subjects:

* Clinical history of the glenohumeral joint
* Prior conservative or operative treatment of the shoulder or elbow
* Range of motion \<90° in abduction and flexion

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

Primary outcomes:
measure: Disabilities of arm, shoulder and hand (Quick DASH) questionnaire
timeFrame: at baseline (approximate duration for all questionnaires: 20 minutes)
measure: Constant Score
timeFrame: at baseline (approximate duration for all questionnaires: 20 minutes)
measure: American Shoulder and Elbow Surgeons (ASES) Shoulder Score
timeFrame: at baseline (approximate duration for all questionnaires: 20 minutes)
measure: Subjective Shoulder Value (SSV)
timeFrame: at baseline (approximate duration for all questionnaires: 20 minutes)
measure: numerical pain rating scale (NRS) score
timeFrame: at baseline (approximate duration for all questionnaires: 20 minutes)
measure: Loaded shoulder abduction test with motion analysis
timeFrame: at baseline (approximate duration for motion analysis: 50 minutes)
measure: Loaded shoulder abduction test with single plane fluoroscopic images
timeFrame: at baseline (approximate duration for motion analysis: 50 minutes).
measure: Load-induced muscle activity from electromyography (EMG)
timeFrame: at baseline (approximate duration for motion analysis: 50 minutes)
measure: Glenohumeral translation from single plane fluoroscopy
timeFrame: at baseline (approximate duration for motion analysis: 50 minutes)
measure: Glenohumeral translation from instrumented motion analysis
timeFrame: at baseline (approximate duration for motion analysis: 50 minutes)
measure: Critical shoulder angle (CSA)
timeFrame: at baseline (approximate duration for motion analysis: 50 minutes)
measure: Glenoid inclination (GI)
timeFrame: at baseline (approximate duration for motion analysis: 50 minutes)
measure: Greater tuberosity angle (GTA)
timeFrame: at baseline (approximate duration for motion analysis: 50 minutes)
measure: Muscle cross sectional area (MCSA)
timeFrame: at baseline (approximate duration is approximately 1 hour and 15 minutes)
measure: Tear size retrieved from MR images
timeFrame: at baseline (approximate duration is approximately 1 hour and 15 minutes)
measure: Tear type retrieved from MR images
timeFrame: at baseline (approximate duration is approximately 1 hour and 15 minutes)
measure: Isometric shoulder muscle strength for abduction and internal/external rotation
timeFrame: at baseline (approximate duration: 40 minutes).
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Orthopaedics and Traumatology, University Hospital Basel
Study officials:
affiliation: Department of Orthopaedics and Traumatology, University Hospital Basel
name: Annegret Mündermann, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: