Electromyography Evaluation of Subscapularis Function After Total Shoulder Arthroplasty

NCT00779974 | Completed

• 1 other identifier: IRB#27370
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis

Keywords

Total Shoulder Arthroplasty; Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• The primary goal of this study is to document the function of the subscapularis after total shoulder arthroplasty

  end of enrollment

Secondary Outcomes (1)

• The sensitivity and specificity of the belly compression and lift off test will be compared to the results of the ultrasound and electromyography (EMG)

  end of enrollment

Study Arms (1)

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.

Other: Evaluation

Interventions

Evaluation 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.

Also known as: ROM, Ultrasound, EMG, Clinic Evaluation

s/p Total Shoulder Arthroplasty

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• age \>45yrs;
• primary diagnosis of osteoarthritis of the shoulder
• total shoulder replacement performed by Dr. Armstrong between September 2003 through December 2007.

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

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

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (6)

• 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.

  PMID: 12610483 BACKGROUND

• 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.

  PMID: 16085613 BACKGROUND

• 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.

  PMID: 16326718 BACKGROUND

• 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.

  PMID: 14564261 BACKGROUND

• 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.

  PMID: 16979047 BACKGROUND

• 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.

  PMID: 12195247 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• April Armstrong, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 22, 2008
• First Posted: October 24, 2008
• Study Start: August 1, 2008
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: November 3, 2023

Record last verified: 2023-11

Locations

US (1)