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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Katherine Saul, Wake Forest University
ClinicalTrials.gov Identifier:
NCT01459536
First received: October 21, 2011
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

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.


Condition
Rotator Cuff Tear

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Rotator Cuff Function and Muscle Morphology in Older Adults With Rotator Cuff Tear

Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Shoulder strength [ Time Frame: baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: September 2011
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Rotator Cuff Tear-surgical
Health Older Adult Control
Rotator cuff tear - non surgical

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

orthopaedic surgery clinic, community sample

Criteria

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01459536

Locations
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Katherine Saul, PhD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Katherine Saul, Assistant Professor, Wake Forest University
ClinicalTrials.gov Identifier: NCT01459536     History of Changes
Other Study ID Numbers: 14547
Study First Received: October 21, 2011
Last Updated: July 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
Aging

ClinicalTrials.gov processed this record on July 29, 2014