Expired Study
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Hershey, Pennsylvania 17033


Purpose:

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.


Study summary:

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. [1] 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. [5] 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.


Criteria:

Inclusion Criteria: - age >45yrs; - primary diagnosis of osteoarthritis of the shoulder - total shoulder replacement performed by Dr. Armstrong between September 2003 through December 2007. Exclusion Criteria: - Known contraindications to ultrasound and/or EMG - Inability to provide informed consent - History of recent trauma to the shoulder - Typical shoulder pain - Other suspected shoulder pathology (i.e. tumor, infection) - Pregnancy - Bilateral total shoulder arthroplasty


Study is Available At:


Original ID:

IRB#27370


NCT ID:

NCT00779974


Secondary ID:


Study Acronym:


Brief Title:

Electromyography Evaluation of Subscapularis Function After Total Shoulder Arthroplasty


Official Title:

Electromyography Evaluation of Subscapularis Function After Total Shoulder


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

45 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Milton S. Hershey Medical Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case-Only, Time Perspective:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

32


Enrollment Type:

Actual


Overall Contact Information

Official Name:April Armstrong, MD
Principal Investigator
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Study Dates

Start Date:August 2008
Completion Date:June 2013
Completion Type:Actual
Primary Completion Date:June 2013
Primary Completion Type:Actual
Verification Date:February 2015
Last Changed Date:February 25, 2015
First Received Date:October 22, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Primary Outcome
Measure:The primary goal of this study is to document the function of the subscapularis after total shoulder arthroplasty
Time Frame:end of enrollment
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:Evaluation
Description: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.
Arm Name:s/p Total Shoulder Arthroplasty
Other Name:ROM

Study Arms

Study Arm Type:Other
Arm Name:s/p Total Shoulder Arthroplasty
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Milton S. Hershey Medical Center

Samples and Retentions

Study Population: 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.
Sample Method:Non-Probability Sample

Study References

Reference Type:Reference
Citation:Miller SL, Hazrati Y, Klepps S, Chiang A, Flatow EL. Loss of subscapularis function after total shoulder replacement: A seldom recognized problem. J Shoulder Elbow Surg. 2003 Jan-Feb;12(1):29-34.
PMID:12610483
Reference Type:Reference
Citation:Gerber C, Yian EH, Pfirrmann CA, Zumstein MA, Werner CM. Subscapularis muscle function and structure after total shoulder replacement with lesser tuberosity osteotomy and repair. J Bone Joint Surg Am. 2005 Aug;87(8):1739-45.
PMID:16085613
Reference Type:Reference
Citation:Ponce BA, Ahluwalia RS, Mazzocca AD, Gobezie RG, Warner JJ, Millett PJ. Biomechanical and clinical evaluation of a novel lesser tuberosity repair technique in total shoulder arthroplasty. J Bone Joint Surg Am. 2005;87 Suppl 2:1-8.
PMID:16326718
Reference Type:Reference
Citation:Tokish JM, Decker MJ, Ellis HB, Torry MR, Hawkins RJ. The belly-press test for the physical examination of the subscapularis muscle: electromyographic validation and comparison to the lift-off test. J Shoulder Elbow Surg. 2003 Sep-Oct;12(5):427-30.
PMID:14564261
Reference Type:Reference
Citation:Armstrong A, Lashgari C, Teefey S, Menendez J, Yamaguchi K, Galatz LM. Ultrasound evaluation and clinical correlation of subscapularis repair after total shoulder arthroplasty. J Shoulder Elbow Surg. 2006 Sep-Oct;15(5):541-8. Epub 2006 Jul 27.
PMID:16979047
Reference Type:Reference
Citation:Sperling JW, Potter HG, Craig EV, Flatow E, Warren RF. Magnetic resonance imaging of painful shoulder arthroplasty. J Shoulder Elbow Surg. 2002 Jul-Aug;11(4):315-21.
PMID:12195247

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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