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

Osteoarthritis of Shoulder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03921944
• Other study ID #: STUDY00008095
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2024
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Milton S. Hershey Medical Center
• Contact: Padmavathi Ponnuru, PhD
• Phone: 717-531-0003
• Email: pponnuru[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of Shoulder

Intervention

Diagnostic Test:
• CT scan of the shoulders
studies of both operative and nonoperative shoulders

Locations

Country	Name	City	State
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Measurement of strength in both shoulders_Jobe's test	Measurement of Strength: measured by Isometer in Kg	one year post surgery
Other	Measurement of strength in both shoulders_Jobe's test	Measurement of Strength: measured by Isometer in Kg	two year post surgery
Other	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
Other	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
Other	Measurement of strength in both shoulders_Belly Press	Measurement of Strength:Belly Press measured as Positive/Negative/Unable	one year post surgery
Other	Measurement of strength in both shoulders_Belly Press	Measurement of Strength:Belly Press measured as Positive/Negative/Unable	two year post surgery
Other	Measurement of strength in both shoulders_Lift off Test	Measurement of Strength: Lift off Test as Positive/Negative/Unable	one year post surgery
Other	Measurement of strength in both shoulders_Lift off Test	Measurement of Strength: Lift off Test as Positive/Negative/Unable	two year post surgery
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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