Electromyography Evaluation of Subscapularis Function After Total Shoulder Arthroplasty
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|ClinicalTrials.gov Identifier: NCT00779974|
Recruitment Status : Completed
First Posted : October 24, 2008
Last Update Posted : February 27, 2015
The primary objective is to document function of the structurally intact subscapularis after total shoulder arthroplasty by using electromyography. Structural integrity of the subscapularis will be confirmed using ultrasound.
The secondary objective is to determine the diagnostic accuracy of the belly compression and lift off tests in evaluating the integrity and function of the subscapularis when compared to the ultrasound and electromyography (EMG).
This will be accomplished by enrolling and evaluating patients with a primary diagnosis of osteoarthritis who have had a total shoulder replacement preformed by the PI from September 2003 through December 2007.
|Condition or disease||Intervention/treatment|
The functional status of the subscapularis following total shoulder arthroplasty has not been well documented. There is evidence of loss of subscapularis function shown through physical exam in up to 2/3 of patients following total shoulder arthroplasty.  Multiple techniques for subscapularis repair have been demonstrated with varying degrees of post operative function, ranging from 11-66% abnormal function on physical exam. [1-3] The belly compression test and the lift off test, which are the main physical exam tests used for evaluation following surgery, are of questionable reliability as indicators of the functionality of the subscapularis. [4,5] Through comparing ultrasound evidence of an intact subscapularis to physical exam findings it has been recognized that the belly compression test has low sensitivity and specificity for subscapularis integrity.  Internal rotation is often limited in many postoperative total shoulder patients, which could lead to false positive results. This questions the validity of the outcomes of the studies in which the standard of testing function was through exam.
Ultrasound is a reliable exam for illustration of structural damage to the subscapularis tendon but additional testing is needed to evaluate the function of the structurally intact subscapularis. [5,6] Irreparable changes in the muscle function or nerve denervation could also result in false positive belly compression and lift off tests. The ability to accurately determine the functionality of the subscapularis following total shoulder replacement is imperative to clinic management. Although studies have shown functional abnormalities through physical exam, none have documented the functional status of the subscapularis using objective means such as EMG.
|Study Type :||Observational|
|Actual Enrollment :||32 participants|
|Official Title:||Electromyography Evaluation of Subscapularis Function After Total Shoulder|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
s/p Total Shoulder Arthroplasty
The subject population for this study consists of adult patients with a primary diagnosis of osteoarthritis who have had a total shoulder arthroplasty preformed by the PI between September 2003 through December 2007.
For this research study each enrolled subject will have a clinical exam, including range of motion (ROM), and strength testing. The lift off and belly compression tests will be performed. An ultrasound of the shoulder will be done to determine the integrity of the subscapularis tendon. An EMG will be done to determine functionality of the subscapularis.
- The primary goal of this study is to document the function of the subscapularis after total shoulder arthroplasty [ Time Frame: end of enrollment ]
- The sensitivity and specificity of the belly compression and lift off test will be compared to the results of the ultrasound and electromyography (EMG) [ Time Frame: end of enrollment ]
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): NCT00779974
|United States, Pennsylvania|
|Penn State College of Medicine, Penn State Milton S. Herhsey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||April Armstrong, MD||Penn State College of Medicine, Penn State Milton S. Hershey Medical Center|