NCT03921944|Terminated
Study Stopped
low enrollment
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Sponsor study identifier
interventional
3
1 country
1
Study Start
May 2, 2024
Actual (reported)Primary Completion
October 18, 2024
Actual (reported)Study Completion
October 18, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 18, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 27, 2019
Actual (reported)April 19, 2019
Actual (reported)May 2, 2024
Actual (reported)October 18, 2024
Actual (reported)October 18, 2024
Actual (reported)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.
Tear in Rotator Cuff Muscles in both shoulders
one year post surgery
Tear in Rotator Cuff Muscles in both shoulders
two year post surgery
Fatty degeneration in Rotator Cuff Muscles in both shoulders using Goutallier Classification
one year post surgery
Fatty degeneration in Rotator Cuff Muscles in both shoulders using Goutallier Classification
two year post surgery
Fatty atrophy in Rotator Cuff Muscles in both shoulders
one year post surgery
Forward Elevation for Active Range of Motion
one year post surgery
Forward Elevation for Active Range of Motion
two year post surgery
Forward Elevation for Passive Range of Motion
one year post surgery
Subjects will be assessed for the outcome measures at one year and two year timepoints post total shoulder replacement surgery
studies of both operative and nonoperative shoulders
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
April D Armstrong, MD
Milton S. Hershey Medical Center
3 participants (actual enrollment reported by the registry).
First Submitted
February 27, 2019
First Posted
April 19, 2019
Study Start
May 2, 2024
Actual (reported)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
Contact the study team to confirm eligibility.
Primary Completion
October 18, 2024
Actual (reported)Study Completion
October 18, 2024
Actual (reported)Last Updated
October 20, 2026
Record last verified: 2026-08
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Source: ClinicalTrials.gov.
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