ClinicalTrials.gg
TerminatedNCT03921944Updated Oct 20, 2026

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

An interventional study of CT scan of the shoulders in Osteoarthritis of Shoulder, sponsored by Milton S. Hershey Medical Center. Terminated at 1 site in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Milton S. Hershey Medical Center · Not applicable, Interventional, and Treatment

Why this study was terminated
low enrollment
Updated Oct 20, 2026Now TerminatedPrimary completion moved+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
45 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Osteoarthritis of Shoulder

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Keywords

  • shoulder surgery
  • arthritis
  • rotator cuff
03

In context

Arthritis

843 studies on the registry are indexed under Arthritis; 118 are open to participants now.

This study's enrollment of 3 is below the median of 97 across 599 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Milton S. Hershey Medical Center is the lead sponsor of 492 studies on the registry; 60 are open to participants now.

Of its 58 completed or terminated interventional studies of FDA-regulated products, 46 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

Exclusion Criteria:

  • Known to CT/EMG
  • Inability to provide
  • History of recent trauma to the shoulder
  • Atypical shoulder pain
  • Other suspected shoulder pathology (i.e. tumor, infection)
  • Pregnancy
  • Bilateral total shoulder arthroplasty
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • 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

Interventions

  • Diagnostic testCT scan of the shoulders

    studies of both operative and nonoperative shoulders

    Also known as: EMG of the shoulders

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: one year post surgery

  2. 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.

    Time frame: two year post surgery

  3. 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.

    Time frame: one year post surgery

  4. 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.

    Time frame: two year post surgery

  5. 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.

    Time frame: one year post surgery

  6. 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.

    Time frame: two year post surgery

  7. 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.

    Time frame: one year post surgery

  8. 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.

    Time frame: two year post surgery

  9. 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.

    Time frame: one year post surgery

  10. 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.

    Time frame: two year post surgery

  11. 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.

    Time frame: one year post surgery

  12. 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.

    Time frame: two year post surgery

Secondary outcomes

  1. 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).

    Time frame: one year post surgery

  2. 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).

    Time frame: two year post surgery

  3. 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.

    Time frame: one year post surgery

  4. 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.

    Time frame: two year post surgery

  5. 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.

    Time frame: one year post surgery

  6. 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.

    Time frame: two year post surgery

Other outcomes

  1. 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.

    Time frame: one year post surgery

  2. 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.

    Time frame: two year post surgery

  3. 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.

    Time frame: one year post surgery

  4. 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.

    Time frame: two year post surgery

  5. 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.

    Time frame: one year post surgery

  6. 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.

    Time frame: two year post surgery

  7. 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.

    Time frame: one year post surgery

  8. 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.

    Time frame: two year post surgery

  9. 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

    Time frame: one year post surgery

  10. 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

    Time frame: two year post surgery

  11. Measurement of strength in both shoulders_Jobe's test

    Measurement of Strength: measured by Isometer in Kg

    Time frame: one year post surgery

  12. Measurement of strength in both shoulders_Jobe's test

    Measurement of Strength: measured by Isometer in Kg

    Time frame: two year post surgery

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

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

    Time frame: one year post surgery

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

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

    Time frame: two year post surgery

  15. Measurement of strength in both shoulders_Belly Press

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

    Time frame: one year post surgery

  16. Measurement of strength in both shoulders_Belly Press

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

    Time frame: two year post surgery

  17. Measurement of strength in both shoulders_Lift off Test

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

    Time frame: one year post surgery

  18. Measurement of strength in both shoulders_Lift off Test

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

    Time frame: two year post surgery

07

Study locations

1 site
  • Penn State Hershey Medical Center
    Hershey, Pennsylvania 17033, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Ran from May 2024 to primary completion in Oct 2024, 5 months.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 20, 2026: primary completion Sep 2028 → Oct 2024 and completion Dec 2028 → Oct 2024.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Feb 27, 2019
First posted
Apr 19, 2019
StartActual
May 2, 2024
Primary completionActual
Oct 18, 2024was Sep 2028
CompletionActual
Oct 18, 2024was Dec 2028
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Terminated low enrollment
changed Oct 20, 2026
Primary completion
Sep 2028→Oct 18, 2024 (actual)
Oct 20, 2026
Study completion
Dec 2028→Oct 18, 2024 (actual)
Oct 20, 2026
Enrollment
30 (estimated)→3 (actual)
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    Recruiting→Terminated
    Why stopped low enrollment
    Primary completion Sep 2028→Oct 18, 2024 (now actual)
    Study completion Dec 2028→Oct 18, 2024 (now actual)
    Enrollment 30 (estimated)→3 (actual)
    + 2 other changes: contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT03921944
Responsible party
April Armstrong (Professor of Surgery, Orthopaedics, Penn State Health Milton S Hershey Medical Center) — Principal investigator
First posted
Apr 19, 2019
Start date
May 2, 2024
Primary completion
Oct 18, 2024
Completion
Oct 18, 2024
Last update
Oct 20, 2026

Study contacts

April D Armstrong, MD
principal investigator · Milton S. Hershey Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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