Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03921944
Recruitment Status : Not yet recruiting
First Posted : April 19, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
April Armstrong, Milton S. Hershey Medical Center

Brief Summary:
The purpose of this study is to examine the rotator cuff muscles in your shoulder at one year post total shoulder replacement surgery.

Condition or disease Intervention/treatment Phase
Osteoarthritis of Shoulder Diagnostic Test: CT scan of the shoulders Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Structural and Functional Integrity of the Rotator Cuff After Total Shoulder Arthroplasty
Estimated Study Start Date : June 3, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
one year post total shoulder surgery Diagnostic Test: CT scan of the shoulders
studies of both operative and nonoperative shoulders
Other Name: EMG of the shoulders




Primary Outcome Measures :
  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 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.

  2. Neuropathic Changes_amplitude [ Time Frame: one year post surgery ]
    The EMG Examination will be performed on the muscles to look for the presence or absence of neuropathic changes assessed by examining unit morphology amplitude: measured in millivolts

  3. Neuropathic Changes_recruitment pattern [ Time Frame: one year post surgery ]
    The EMG Examination will be performed on the muscles 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

  4. Neuropathic Changes_duration [ Time Frame: one year post surgery ]
    The EMG Examination will be performed on the muscles to look for the presence or absence of neuropathic changes assessed by examining unit morphology: duration measured in milliseconds.

  5. Total number of Muscles affected [ Time Frame: one year post surgery ]
    The EMG Examination will be performed to look for abnormal changes as indicated ny presence of active nerve denervation across the 5 muscles (upper subscapularis, Infraspinatus, Supraspinatus, teres minor, Rhomboid)


Secondary Outcome Measures :
  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 massive

  2. Fatty atrophy in Rotator Cuff Muscles in both shoulders [ 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 six stages, ranging from Stage 0 (normal muscle) to Stage 5 (more fat than muscle).

  3. Fatty degeneration 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


Other Outcome Measures:
  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 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.

  3. 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.

  4. 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.

  5. 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


  6. Measurement of strength in both shoulders_Jobe's test [ Time Frame: one year post surgery ]
    Measurement of Strength: Jobe's Test measured as- 5/4/3/2/1

  7. Measurement of strength in both shoulders_External Rotation (at side) [ Time Frame: one year post surgery ]
    Measurement of Strength: External Rotation (at side) measured as 5/4/3/2/1

  8. Measurement of strength in both shoulders_Belly Press [ Time Frame: one year post surgery ]
    Measurement of Strength:Belly Press measured as Positive/Negative/Unable

  9. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921944


Contacts
Layout table for location contacts
Contact: Padmavathi Ponnuru, PhD 717-531-0003 ext 284476 pponnuru@pennstatehealth.psu.edu

Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Layout table for investigator information
Principal Investigator: April D Armstrong, MD Milton S. Hershey Medical Center

Layout table for additonal information
Responsible Party: April Armstrong, Professor of Surgery, Orthopaedics, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03921944     History of Changes
Other Study ID Numbers: STUDY00008095
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by April Armstrong, Milton S. Hershey Medical Center:
shoulder surgery
arthritis
rotator cuff

Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases