Evaluation of Structural and Functional Integrity of the Rotator Cuff After Total Shoulder Arthroplasty

Study Overview
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Brief Summary
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The purpose of this study is to examine the rotator cuff muscles in your shoulder at one and two year post total shoulder replacement surgery.

Official Title
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Evaluation of Structural and Functional Integrity of the Rotator Cuff After Total Shoulder Arthroplasty

Conditions
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Osteoarthritis of Shoulder

Intervention / Treatment
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* Diagnostic Test: CT scan of the shoulders


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age >45yrs primary diagnosis of osteoarthritis of the shoulder total shoulder replacement performed by Dr. Armstrong administered a local anesthetic mixture and not regional anesthesia all genders Fluent in written and spoken English Patients capable of giving informed consent Exclusion Criteria: Known contraindications to CT/EMG Inability to provide informed consent History of recent trauma to the shoulder Atypical shoulder pain Other suspected shoulder pathology (i.e. tumor, infection) Pregnancy Bilateral total shoulder arthroplasty

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: total shoulder replacement surgery<br>Subjects will be assessed for the outcome measures at one year and two year timepoints post total shoulder replacement surgery | Diagnostic Test: CT scan of the shoulders<br>* studies of both operative and nonoperative shoulders<br>* Other names: EMG of the shoulders;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Active Nerve Denervation | EMG examination will be performed by a single neurologist. The EMG Examination will be performed on the muscles (upper subscapularis, supraspinatus, infraspinatus, teres minor and rhomboid) to look for any presence or absence of active denervation. Presence indicated by increased insertional activity, fibrillation potential, positive sharp waves and/or with fasciculations in both operated and unoperated shoulders. | one year post surgery | 
| Active Nerve Denervation | EMG examination will be performed by a single neurologist. The EMG Examination will be performed on the muscles (upper subscapularis, supraspinatus, infraspinatus, teres minor and rhomboid) to look for any presence or absence of active denervation. Presence indicated by increased insertional activity, fibrillation potential, positive sharp waves and/or with fasciculations in both operated and unoperated shoulders. | two year post surgery | 
| Neuropathic Changes_amplitude | The EMG Examination will be performed on the muscles (upper subscapularis, supraspinatus, infraspinatus, teres minor and rhomboid) to look for the presence or absence of neuropathic changes assessed by examining unit morphology amplitude: measured in millivolts, in both operated and unoperated shoulders. | one year post surgery | 
| Neuropathic Changes_amplitude | The EMG Examination will be performed on the muscles (upper subscapularis, supraspinatus, infraspinatus, teres minor and rhomboid) to look for the presence or absence of neuropathic changes assessed by examining unit morphology amplitude: measured in millivolts, in both operated and unoperated shoulders. | two year post surgery | 
| Neuropathic Changes_recruitment pattern | The EMG Examination will be performed on the muscles (upper subscapularis, supraspinatus, infraspinatus, teres minor and rhomboid) to look for the presence or absence of neuropathic changes assessed by examining unit morphology: phases with recruitment pattern measured as 1-2 or 3-4 units in both operated and unoperated shoulders. | one year post surgery | 
| Neuropathic Changes_recruitment pattern | The EMG Examination will be performed on the muscles (upper subscapularis, supraspinatus, infraspinatus, teres minor and rhomboid) to look for the presence or absence of neuropathic changes assessed by examining unit morphology: phases with recruitment pattern measured as 1-2 or 3-4 units in both operated and unoperated shoulders. | two year post surgery | 
| Neuropathic Changes_duration | The EMG Examination will be performed on the muscles in both operated and unoperated shoulders to look for the presence or absence of neuropathic changes assessed by examining unit morphology: duration measured in milliseconds. | one year post surgery | 
| Neuropathic Changes_duration | The EMG Examination will be performed on the muscles in both operated and unoperated shoulders to look for the presence or absence of neuropathic changes assessed by examining unit morphology: duration measured in milliseconds. | two year post surgery | 
| Total number of Muscles affected with active denervation | The EMG Examination will be performed to look for abnormal changes as indicated by presence of active nerve denervation across the 5 muscles (upper subscapularis, Infraspinatus, Supraspinatus, teres minor, Rhomboid) in both operated and unoperated shoulders. | one year post surgery | 
| Total number of Muscles affected with active denervation | The EMG Examination will be performed to look for abnormal changes as indicated by presence of active nerve denervation across the 5 muscles (upper subscapularis, Infraspinatus, Supraspinatus, teres minor, Rhomboid) in both operated and unoperated shoulders. | two year post surgery | 
| Total number of muscles affected with neuropathic changes | The EMG Examination will be performed to look for neuropathic changes as indicated by amplitude, recruitment pattern and duration across the 5 muscles (upper subscapularis, Infraspinatus, Supraspinatus, teres minor, Rhomboid) in both operated and unoperated shoulders. | one year post surgery | 
| Total number of muscles affected with neuropathic changes | The EMG Examination will be performed to look for neuropathic changes as indicated by amplitude, recruitment pattern and duration across the 5 muscles (upper subscapularis, Infraspinatus, Supraspinatus, teres minor, Rhomboid) in both operated and unoperated shoulders. | two year post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear in Rotator Cuff Muscles in both shoulders | CT Scan to evaluate rotator cuff muscles for presence or absence of any tear in operative and non-operative. If tear is present - partial or full. If full, small or (<1cm), or medium (1-3 cm_ or Large (3-5 cm) or massive (>5cm), tendon involved (supraspinatus or infraspinatus or subscapularis). | one year post surgery | 
| Tear in Rotator Cuff Muscles in both shoulders | CT Scan to evaluate rotator cuff muscles for presence or absence of any tear in operative and non-operative. If tear is present - partial or full. If full, small or (<1cm), or medium (1-3 cm_ or Large (3-5 cm) or massive (>5cm), tendon involved (supraspinatus or infraspinatus or subscapularis). | two year post surgery | 
| Fatty degeneration in Rotator Cuff Muscles in both shoulders using Goutallier Classification | CT scan to evaluate atrophy in Rotator Cuff Muscles using the Goutallier Classification System. The Classification system measures fatty tissue infiltration and has five stages, ranging from Stage 0 (normal muscle) to Stage 4 (more fat than muscle) in upper subscapularis, infraspinatus, supraspinatus, teres minor and rhomboid in both operated and unoperated shoulder. | one year post surgery | 
| Fatty degeneration in Rotator Cuff Muscles in both shoulders using Goutallier Classification | CT scan to evaluate atrophy in Rotator Cuff Muscles using the Goutallier Classification System. The Classification system measures fatty tissue infiltration and has five stages, ranging from Stage 0 (normal muscle) to Stage 4 (more fat than muscle) in upper subscapularis, infraspinatus, supraspinatus, teres minor and rhomboid in both operated and unoperated shoulder. | two year post surgery | 
| Fatty atrophy in Rotator Cuff Muscles in both shoulders | CT Scan to evaluate fatty degeneration in Rotator Cuff Muscles - present or absent in upper subscapularis, infraspinatus, supraspinatus, teres minor and rhomboid muscles in both operated and unoperated shoulders. | one year post surgery | 
| Fatty atrophy in Rotator Cuff Muscles in both shoulders | CT Scan to evaluate fatty degeneration in Rotator Cuff Muscles - present or absent in upper subscapularis, infraspinatus, supraspinatus, teres minor and rhomboid muscles in both operated and unoperated shoulders. | two year post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shoulder surgery, arthritis, rotator cuff