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

Not Applicable

Recruiting

• Conditions: Osteoarthritis of Shoulder
• Interventions: Diagnostic Test: CT scan of the shoulders

• Registration Number: NCT03921944
• Lead Sponsor: Milton S. Hershey Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-27
• Study First Submitted QC: 2019-04-17
• Study First Posted: 2019-04-19
• Status Verified: 2024-05
• Study Start: 2024-05-02
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-09
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
total shoulder replacement surgery	CT scan of the shoulders	Subjects will be assessed for the outcome measures at one year and two year timepoints post total shoulder replacement surgery

Primary Outcome Measures

Name	Time	Method
Neuropathic Changes_recruitment pattern	two year post surgery	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.
Active Nerve Denervation	two year post surgery	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	two year post surgery	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_duration	two year post surgery	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.
Total number of Muscles affected with active denervation	two year post surgery	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.
Total number of muscles affected with neuropathic changes	two year post surgery	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.

Secondary Outcome Measures

Name	Time	Method
Tear in Rotator Cuff Muscles in both shoulders	two year post surgery	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	two year post surgery	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 atrophy in Rotator Cuff Muscles in both shoulders	two year post surgery	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.

Trial Locations

Locations (1)

Penn State Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States