Assessment of Muscle Function and Size in Older Adults With Rotator Cuff Tear

Rotator Cuff Tear Clinical Trial

— ARC  

Official title:

Rotator Cuff Function and Muscle Morphology in Older Adults With Rotator Cuff Tear

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01459536
• Other study ID #: 14547
• Status: Completed
• Phase: N/A
• First received: October 21, 2011
• Last updated: November 3, 2017
• Start date: September 2011
• Est. completion date: December 2013

Study information

• Verified date: March 2017
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Adequate upper limb function is critically important to maintenance of independence and prevention of disability in older adults. The goal of this work is to identify factors that contribute to rotator cuff rupture and improved outcomes for repair. Ultimately, the investigators seek to identify patients most at risk for rupture and to guide clinicians on optimal surgical and rehabilitation strategies. This pilot study will quantitatively characterize the morphological (muscle volume and fatty infiltration) and functional (shoulder isometric joint strength, movement when performing typical task) changes in the muscles of the rotator cuff following supraspinatus tear and surgical repair. The investigators hypothesize that patients with supraspinatus tear will have reduced muscle volume and increased fatty infiltration of rotator cuff muscles compared to their contralateral arm and age-matched controls, which will increase following surgery. The investigators further hypothesize that isometric joint strength in these individuals will be associated with muscle volume and the degree of fatty infiltration, and that older adults with a rotator cuff tear will use a restricted range of motion to accomplish functional tasks. This study emphasizes muscle function and composition with application to rehabilitation of upper limb function, which complements the theme of the Pepper Center.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• adults = 60 years of age

• free of any medical condition that might be exacerbated by physical testing

• patients: major thickness supraspinatus tear

• control subjects: no history of significant injury or pathology in either upper limb

Exclusion Criteria:

• contraindication to undergoing MRI

• history of neuromuscular disorder, or any injury that may affect the upper limb (e.g. any history of stroke, Parkinson's, or spinal cord injury, or being confined to a wheelchair)

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder strength		baseline