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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis of Shoulder
• Intervention / Treatment: Diagnostic test: CT scan of the shoulders

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Padmavathi Ponnuru, PhD; Phone Number: 284476 717-531-0003; Email: pponnuru@pennstatehealth.psu.edu

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Recruiting
      • Penn State Hershey Medical Center
      • Contact: Padmavathi Ponnuru, Ph.D.; Phone Number: 284476 717-531-0003; Email: pponnuru@pennstatehealth.psu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: total shoulder replacement surgery; 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; studies of both operative and nonoperative shoulders; Other Names: EMG of the shoulders

What is the study measuring?

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
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_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_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
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 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
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.	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.	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.	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.	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.	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
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 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
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.	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.	two year post surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	one year post surgery
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.	one year post surgery
External Rotation (side) for Passive Range of Motion	A physical exam will be performed on both shoulders to asses external rotation (side) for passive range of motion using a Goniometer.	one year post surgery
External Rotation (side) for Active Range of Motion	A physical exam will be performed on both shoulders to asses external rotation (side) for active range of motion using a Goniometer.	one year post surgery
Range of Motion in both shoulders_ Internal Rotation	Physical exam to see range of motion includes: Internal Rotation measured as T5 or T7 or TL or Belt or Butt or Side	one year post surgery
Measurement of strength in both shoulders_Jobe's test	Measurement of Strength: measured by Isometer in Kg	one year post surgery
Measurement of strength in both shoulders_External Rotation (at side)	Measurement of Strength: External Rotation (at side) measured by Isometer in Kg	one year post surgery
Measurement of strength in both shoulders_Belly Press	Measurement of Strength:Belly Press measured as Positive/Negative/Unable	one year post surgery
Measurement of strength in both shoulders_Lift off Test	Measurement of Strength: Lift off Test as Positive/Negative/Unable	one year post surgery
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.	two year post surgery
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.	two year post surgery
External Rotation (side) for Passive Range of Motion	A physical exam will be performed on both shoulders to asses external rotation (side) for passive range of motion using a Goniometer.	two year post surgery
External Rotation (side) for Active Range of Motion	A physical exam will be performed on both shoulders to asses external rotation (side) for active range of motion using a Goniometer.	two year post surgery
Range of Motion in both shoulders_ Internal Rotation	Physical exam to see range of motion includes: Internal Rotation measured as T5 or T7 or TL or Belt or Butt or Side	two year post surgery
Measurement of strength in both shoulders_Jobe's test	Measurement of Strength: measured by Isometer in Kg	two year post surgery
Measurement of strength in both shoulders_External Rotation (at side)	Measurement of Strength: External Rotation (at side) measured by Isometer in Kg	two year post surgery
Measurement of strength in both shoulders_Belly Press	Measurement of Strength:Belly Press measured as Positive/Negative/Unable	two year post surgery
Measurement of strength in both shoulders_Lift off Test	Measurement of Strength: Lift off Test as Positive/Negative/Unable	two year post surgery

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Investigators: Principal Investigator: April D Armstrong, MD, Milton S. Hershey Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 27, 2019
• First Submitted That Met QC Criteria: April 17, 2019
• First Posted (Actual): April 19, 2019

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: arthritis; rotator cuff; shoulder surgery
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Arthritis
• Other Study ID Numbers: STUDY00008095

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No