Electromyography Evaluation of Subscapularis Function After Total Shoulder Arthroplasty

NCT ID: NCT00779974

Last Updated: 2023-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2013-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Evaluation

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Evaluation

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ROM Ultrasound EMG Clinic Evaluation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

April Armstrong

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

April Armstrong, MD

Role: PRINCIPAL_INVESTIGATOR

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Penn State College of Medicine, Penn State Milton S. Herhsey Medical Center

Hershey, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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. doi: 10.1067/mse.2003.128195.

Reference Type BACKGROUND
PMID: 12610483 (View on PubMed)

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. doi: 10.2106/JBJS.D.02788.

Reference Type BACKGROUND
PMID: 16085613 (View on PubMed)

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. doi: 10.2106/JBJS.E.00441. No abstract available.

Reference Type BACKGROUND
PMID: 16326718 (View on PubMed)

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. doi: 10.1016/s1058-2746(03)00047-8.

Reference Type BACKGROUND
PMID: 14564261 (View on PubMed)

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. doi: 10.1016/j.jse.2005.09.013. Epub 2006 Jul 27.

Reference Type BACKGROUND
PMID: 16979047 (View on PubMed)

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. doi: 10.1067/mse.2002.124426.

Reference Type BACKGROUND
PMID: 12195247 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB#27370

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.