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

Primary Purpose

Osteoarthritis of Shoulder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CT scan of the shoulders
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of Shoulder focused on measuring shoulder surgery, arthritis, rotator cuff

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    total shoulder replacement surgery

    Arm Description

    Subjects will be assessed for the outcome measures at one year and two year timepoints post total shoulder replacement surgery

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    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).
    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).
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    February 27, 2019
    Last Updated
    August 29, 2023
    Sponsor
    Milton S. Hershey Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03921944
    Brief Title
    Evaluation of Structural and Functional Integrity of the Rotator Cuff After Total Shoulder Arthroplasty
    Official Title
    Evaluation of Structural and Functional Integrity of the Rotator Cuff After Total Shoulder Arthroplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 15, 2023 (Anticipated)
    Primary Completion Date
    September 2024 (Anticipated)
    Study Completion Date
    September 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Milton S. Hershey Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis of Shoulder
    Keywords
    shoulder surgery, arthritis, rotator cuff

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    total shoulder replacement surgery
    Arm Type
    Other
    Arm Description
    Subjects will be assessed for the outcome measures at one year and two year timepoints post total shoulder replacement surgery
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    CT scan of the shoulders
    Other Intervention Name(s)
    EMG of the shoulders
    Intervention Description
    studies of both operative and nonoperative shoulders
    Primary Outcome Measure Information:
    Title
    Active Nerve Denervation
    Description
    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
    Title
    Active Nerve Denervation
    Description
    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
    Title
    Neuropathic Changes_amplitude
    Description
    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
    Title
    Neuropathic Changes_amplitude
    Description
    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
    Title
    Neuropathic Changes_recruitment pattern
    Description
    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
    Title
    Neuropathic Changes_recruitment pattern
    Description
    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
    Title
    Neuropathic Changes_duration
    Description
    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
    Title
    Neuropathic Changes_duration
    Description
    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
    Title
    Total number of Muscles affected with active denervation
    Description
    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
    Title
    Total number of Muscles affected with active denervation
    Description
    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
    Title
    Total number of muscles affected with neuropathic changes
    Description
    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
    Title
    Total number of muscles affected with neuropathic changes
    Description
    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 Outcome Measure Information:
    Title
    Tear in Rotator Cuff Muscles in both shoulders
    Description
    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
    Title
    Tear in Rotator Cuff Muscles in both shoulders
    Description
    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
    Title
    Fatty degeneration in Rotator Cuff Muscles in both shoulders using Goutallier Classification
    Description
    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
    Title
    Fatty degeneration in Rotator Cuff Muscles in both shoulders using Goutallier Classification
    Description
    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
    Title
    Fatty atrophy in Rotator Cuff Muscles in both shoulders
    Description
    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
    Title
    Fatty atrophy in Rotator Cuff Muscles in both shoulders
    Description
    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 Pre-specified Outcome Measures:
    Title
    Forward Elevation for Active Range of Motion
    Description
    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
    Title
    Forward Elevation for Active Range of Motion
    Description
    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
    Title
    Forward Elevation for Passive Range of Motion
    Description
    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
    Title
    Forward Elevation for Passive Range of Motion
    Description
    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
    Title
    External Rotation (side) for Passive Range of Motion
    Description
    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
    Title
    External Rotation (side) for Passive Range of Motion
    Description
    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
    Title
    External Rotation (side) for Active Range of Motion
    Description
    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
    Title
    External Rotation (side) for Active Range of Motion
    Description
    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
    Title
    Range of Motion in both shoulders_ Internal Rotation
    Description
    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
    Title
    Range of Motion in both shoulders_ Internal Rotation
    Description
    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
    Title
    Measurement of strength in both shoulders_Jobe's test
    Description
    Measurement of Strength: measured by Isometer in Kg
    Time Frame
    one year post surgery
    Title
    Measurement of strength in both shoulders_Jobe's test
    Description
    Measurement of Strength: measured by Isometer in Kg
    Time Frame
    two year post surgery
    Title
    Measurement of strength in both shoulders_External Rotation (at side)
    Description
    Measurement of Strength: External Rotation (at side) measured by Isometer in Kg
    Time Frame
    one year post surgery
    Title
    Measurement of strength in both shoulders_External Rotation (at side)
    Description
    Measurement of Strength: External Rotation (at side) measured by Isometer in Kg
    Time Frame
    two year post surgery
    Title
    Measurement of strength in both shoulders_Belly Press
    Description
    Measurement of Strength:Belly Press measured as Positive/Negative/Unable
    Time Frame
    one year post surgery
    Title
    Measurement of strength in both shoulders_Belly Press
    Description
    Measurement of Strength:Belly Press measured as Positive/Negative/Unable
    Time Frame
    two year post surgery
    Title
    Measurement of strength in both shoulders_Lift off Test
    Description
    Measurement of Strength: Lift off Test as Positive/Negative/Unable
    Time Frame
    one year post surgery
    Title
    Measurement of strength in both shoulders_Lift off Test
    Description
    Measurement of Strength: Lift off Test as Positive/Negative/Unable
    Time Frame
    two year post surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Padmavathi Ponnuru, PhD
    Phone
    717-531-0003
    Ext
    284476
    Email
    pponnuru@pennstatehealth.psu.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    April D Armstrong, MD
    Organizational Affiliation
    Milton S. Hershey Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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