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Subscapularis Strength After Total Shoulder Arthroplasty

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ClinicalTrials.gov Identifier: NCT03854357
Recruitment Status : Recruiting
First Posted : February 26, 2019
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Lafi Khalil, Henry Ford Health System

Brief Summary:
This is a randomized, double-blinded, standard of care-controlled clinical trial. The purpose of this study is to determine the difference in subscapularis strength and function after anatomic Total Shoulder Arthroplasty (aTSA) in patients who receive isolated subscapularis rehabilitation in addition to the standard rehabilitation after surgery at 12-month follow up. Specifically the investigators will measure subscapularis strength utilizing a dynamometer device and subscapularis function utilizing isolated subscapularis physical examination testing: belly-press, bear-hug, and lift-off tests. Additionally, investigators will document secondary outcome measures including shoulder range of motion and Patient Reported Outcome Measure Information System (PROMIS) questionnaire scores.

Condition or disease Intervention/treatment Phase
Shoulder Osteoarthritis Procedure: Subscapularis Rehabilitation Procedure: Standard Rehabilitation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Focused Rehabilitation on Subscapularis Strength After Total Shoulder Arthroplasty
Actual Study Start Date : October 2, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Additional Isolated Subscapularis Rehabilitation
Patients will be randomized to receive additional isolated subscapularis specific rehabilitation exercises during their standard post-operative physical therapy sessions after anatomic total shoulder arthroplasty.
Procedure: Subscapularis Rehabilitation
Specific subscapularis rehabilitation exercises which are not included in the current, standard rehabilitation protocol assigned to total shoulder arthroplasty patients post-operatively.

Procedure: Standard Rehabilitation
Standard post-operative rehabiliation protocol assigned to all total shoulder arthroplasty patients postoperatively

Active Comparator: Standard Post-Operative TSA Rehabilitation
Patients will be randomized to receive additional isolated subscapularis specific rehabilitation exercises during their standard post-operative physical therapy sessions after anatomic total shoulder arthroplasty.
Procedure: Standard Rehabilitation
Standard post-operative rehabiliation protocol assigned to all total shoulder arthroplasty patients postoperatively




Primary Outcome Measures :
  1. Subscapularis Strength [ Time Frame: 12 months post-operative follow-up ]
    Subscapularis strength is the single, primary outcome measure. It will be measured by a dynamometer device, which is a device that patient holds in their hand and presses against a static object (such as a wall), creating force which is measured by the device. The device records this force as pounds (lb). Therefore, the investigators will use the dynamometer device to measure the single, primary outcome measure of strength (of the subscapularis muscle), with the single output unit of "pounds of force" in order to measure changes in strength from pre-operative testing to post-operative testing (at 3, 6, and 12 month post-operative time points).


Secondary Outcome Measures :
  1. Shoulder Range of Motion [ Time Frame: 12 months post-operative follow-up ]
    Shoulder range of motion will be measured using a goniometer at all time points, to compare improvement in range of motion from preoperative to post-operative testing time points. A goniometer is a device which allows an investigator to measure a subject's range of motion of a limb or extremity using the unit of measure "degrees" in all planes of motion. Investigators will measure the range of motion of the subject's shoulder (upper extremity) in the following planes: forward flexion, abduction, external rotation, abduction external rotation, and abduction internal rotation. These will be compared from pre-operative baseline measurements through 12-month post-operative measurements.

  2. Patient Reported Outcome Measure Information System [ Time Frame: 12 months post-operative follow-up ]
    Patient reported outcomes will be collected through a series of questionnaires administered at each time point: preoperative, and 3, 6, and 12 month postoperative clinic visits. The investigators will administer the questionnaire to the subjects, which includes the Patient Reported Outcome Measurement Information System (PROMIS) outcome score questionnaire. The PROMIS scores from this questionnaire are scaled from a minimum score of 0 to a maximum score of 100, where 50 is the mean, and 10 is the standard deviation. The scores of the patients will be compared from baseline preoperative recordings through the 12-month post-operative follow up.

  3. Subscapularis Function [ Time Frame: 12 months post-operative follow up. ]
    Subscapularis function will be determined as either "intact" or "deficient" based on the clinical examination of the subscapularis muscle using functional provocative tests such as the belly press, bear hug, and lift off lag test for subscapularis function at each respective time point. These tests are clinical tests which investigators use in clinic to evaluate the ability of the subscapularis muscle to function. Depending on body habitus and shoulder range of motion, patients may be unable to perform some or all of these tests. For this reason, one test will be administered to any given patient, depending on which test they are able to perform. The outcome of the test will be reported as either an intact or a deficient subscapularis tendon function. Therefore this will account for one outcome measure of subscapularis function.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All adult patients over the age of 18
  • Must have a diagnosis of glenohumeral osteoarthritis
  • Must be scheduled for primary anatomic total shoulder arthroplasty.

Exclusion Criteria:

  • History of prior rotator cuff surgery
  • Rotator cuff deficiency
  • Planned reverse total shoulder arthroplasty
  • inflammatory arthropathy
  • prior shoulder replacement surgery
  • neurologic deficits of the affected extremity
  • diagnosis of frozen shoulder
  • previous infection in the shoulder.

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): NCT03854357


Contacts
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Contact: Lafi S Khalil, MD 3139325657 lkhalil2@hfhs.org
Contact: Lafi S Khalil, MD 3139325657 lskhalil@gmail.com

Locations
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United States, Michigan
Henry Ford Health Systems Recruiting
Detroit, Michigan, United States, 48202
Contact: Lafi S Khalil, MD    313-932-5657    lkhalil2@hfhs.org   
Sponsors and Collaborators
Henry Ford Health System
Investigators
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Principal Investigator: Lafi S Khalil, MD Henry Ford Health System

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Responsible Party: Lafi Khalil, Principal Investigator, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT03854357     History of Changes
Other Study ID Numbers: 12088
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lafi Khalil, Henry Ford Health System:
Subscapularis
Total Shoulder Arthroplasty
Subscapularis Rehabilitation
Subscapularis strength
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases