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NCT Number: NCT03921944

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.

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Key information

Conditions

Osteoarthritis of Shoulder Arthritis Joint Diseases Musculoskeletal Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location status: Recruiting

Location contact

Padmavathi Ponnuru, Ph.D.

CONTACT

[email protected]

717-531-0003 ext. 284476

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT scan of the shoulders

Diagnostic Test

studies of both operative and nonoperative shoulders

Other names: EMG of the shoulders

Primary outcomes

  1. Active Nerve Denervation

    Time frame: one 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.

  2. Active Nerve Denervation

    Time frame: 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.

  3. Neuropathic Changes_amplitude

    Time frame: one 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.

  4. Neuropathic Changes_amplitude

    Time frame: 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.

  5. Neuropathic Changes_recruitment pattern

    Time frame: one 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.

  6. Neuropathic Changes_recruitment pattern

    Time frame: 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.

  7. Neuropathic Changes_duration

    Time frame: one 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.

  8. Neuropathic Changes_duration

    Time frame: 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.

  9. Total number of Muscles affected with active denervation

    Time frame: one 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.

  10. Total number of Muscles affected with active denervation

    Time frame: 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.

  11. Total number of muscles affected with neuropathic changes

    Time frame: one 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.

  12. Total number of muscles affected with neuropathic changes

    Time frame: 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 outcomes

  1. Tear in Rotator Cuff Muscles in both shoulders

    Time frame: one 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).

  2. Tear in Rotator Cuff Muscles in both shoulders

    Time frame: 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).

  3. Fatty degeneration in Rotator Cuff Muscles in both shoulders using Goutallier Classification

    Time frame: one 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.

  4. Fatty degeneration in Rotator Cuff Muscles in both shoulders using Goutallier Classification

    Time frame: 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.

  5. Fatty atrophy in Rotator Cuff Muscles in both shoulders

    Time frame: one 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.

  6. Fatty atrophy in Rotator Cuff Muscles in both shoulders

    Time frame: 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.

Other outcomes

  1. Forward Elevation for Active Range of Motion

    Time frame: one year post surgery

    A physical exam will be performed on both shoulders to asses forward elevation on active range of motion using a Goniometer.

  2. Forward Elevation for Active Range of Motion

    Time frame: two year post surgery

    A physical exam will be performed on both shoulders to asses forward elevation on active range of motion using a Goniometer.

  3. Forward Elevation for Passive Range of Motion

    Time frame: one year post surgery

    A physical exam will be performed on both shoulders to asses forward elevation for passive range of motion using a Goniometer.

  4. Forward Elevation for Passive Range of Motion

    Time frame: two year post surgery

    A physical exam will be performed on both shoulders to asses forward elevation for passive range of motion using a Goniometer.

  5. External Rotation (side) for Passive Range of Motion

    Time frame: one year post surgery

    A physical exam will be performed on both shoulders to asses external rotation (side) for passive range of motion using a Goniometer.

  6. External Rotation (side) for Passive Range of Motion

    Time frame: two year post surgery

    A physical exam will be performed on both shoulders to asses external rotation (side) for passive range of motion using a Goniometer.

  7. External Rotation (side) for Active Range of Motion

    Time frame: one year post surgery

    A physical exam will be performed on both shoulders to asses external rotation (side) for active range of motion using a Goniometer.

  8. External Rotation (side) for Active Range of Motion

    Time frame: two year post surgery

    A physical exam will be performed on both shoulders to asses external rotation (side) for active range of motion using a Goniometer.

  9. Range of Motion in both shoulders_ Internal Rotation

    Time frame: one year post surgery

    Physical exam to see range of motion includes:

    Internal Rotation measured as T5 or T7 or TL or Belt or Butt or Side

  10. Range of Motion in both shoulders_ Internal Rotation

    Time frame: two year post surgery

    Physical exam to see range of motion includes:

    Internal Rotation measured as T5 or T7 or TL or Belt or Butt or Side

  11. Measurement of strength in both shoulders_Jobe's test

    Time frame: one year post surgery

    Measurement of Strength: measured by Isometer in Kg

  12. Measurement of strength in both shoulders_Jobe's test

    Time frame: two year post surgery

    Measurement of Strength: measured by Isometer in Kg

  13. Measurement of strength in both shoulders_External Rotation (at side)

    Time frame: one year post surgery

    Measurement of Strength: External Rotation (at side) measured by Isometer in Kg

  14. Measurement of strength in both shoulders_External Rotation (at side)

    Time frame: two year post surgery

    Measurement of Strength: External Rotation (at side) measured by Isometer in Kg

  15. Measurement of strength in both shoulders_Belly Press

    Time frame: one year post surgery

    Measurement of Strength:Belly Press measured as Positive/Negative/Unable

  16. Measurement of strength in both shoulders_Belly Press

    Time frame: two year post surgery

    Measurement of Strength:Belly Press measured as Positive/Negative/Unable

  17. Measurement of strength in both shoulders_Lift off Test

    Time frame: one year post surgery

    Measurement of Strength: Lift off Test as Positive/Negative/Unable

  18. Measurement of strength in both shoulders_Lift off Test

    Time frame: two year post surgery

    Measurement of Strength: Lift off Test as Positive/Negative/Unable

Study contacts

Contact information is provided by the study sponsor or research team.

Padmavathi Ponnuru, PhD

CONTACT

[email protected]

717-531-0003 ext. 284476

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 19, 2019
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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