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

NCT03921944 | Recruiting

• 1 other identifier: STUDY00008095
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis of Shoulder

Keywords

shoulder surgery; arthritis; rotator cuff

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (6)

• 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

Other Outcomes (18)

• 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

Study Arms (1)

total shoulder replacement surgery

OTHER

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

Interventions

CT scan of the shoulders DIAGNOSTIC_TEST

studies of both operative and nonoperative shoulders

Also known as: EMG of the shoulders

total shoulder replacement surgery

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

RECRUITING

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• April D Armstrong, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Padmavathi Ponnuru, PhD

CONTACT

717-531-0003; pponnuru@pennstatehealth.psu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery, Orthopaedics

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: April 19, 2019
• Study Start: May 2, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)