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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03921944
Enrollment
30
Registered
2019-04-19
Start date
2024-05-02
Completion date
2028-12-01
Last updated
2026-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of Shoulder

Keywords

shoulder surgery, arthritis, rotator cuff

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.

Interventions

DIAGNOSTIC_TESTCT scan of the shoulders

studies of both operative and nonoperative shoulders

Sponsors

Milton S. Hershey Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Active Nerve Denervationone year post surgeryEMG 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_amplitudeone year post surgeryThe 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_recruitment patternone year post surgeryThe 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.
Neuropathic Changes_durationone year post surgeryThe 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 denervationone year post surgeryThe 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 changesone year post surgeryThe 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

MeasureTime frameDescription
Tear in Rotator Cuff Muscles in both shouldersone year post surgeryCT 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 Classificationone year post surgeryCT 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 shouldersone year post surgeryCT 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.

Countries

United States

Contacts

CONTACTPadmavathi Ponnuru, PhD
pponnuru@pennstatehealth.psu.edu717-531-0003
PRINCIPAL_INVESTIGATORApril D Armstrong, MD

Milton S. Hershey Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 14, 2026