About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Known contraindications to CT/EMG
Inability to provide informed consent
History of recent trauma to the shoulder
Atypical shoulder pain
Trial design
Single group
Treatments tested in this trial
CT scan of the shoulders
Diagnostic teststudies of both operative and nonoperative shoulders
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Secondary outcomes
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).
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).
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.
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.
Other outcomes
Forward Elevation for Active Range of Motion
A physical exam will be performed on both shoulders to asses forward elevation on active range of motion using a Goniometer.
Forward Elevation for Active Range of Motion
A physical exam will be performed on both shoulders to asses forward elevation on active range of motion using a Goniometer.
Forward Elevation for Passive Range of Motion
A physical exam will be performed on both shoulders to asses forward elevation for passive range of motion using a Goniometer.
Forward Elevation for Passive Range of Motion
A physical exam will be performed on both shoulders to asses forward elevation for passive range of motion using a Goniometer.
Sponsors and contacts
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Milton S. Hershey Medical Center
Lead sponsor
Penn State Health Milton S Hershey Medical Center
Sponsor institution