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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01459536
First Posted: October 25, 2011
Last Update Posted: November 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )
  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

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences ( Wake Forest University ):

Primary Outcome Measures:
  • Shoulder strength [ Time Frame: baseline ]

Enrollment: 25
Study Start Date: September 2011
Study Completion Date: December 2013
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

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01459536


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT01459536     History of Changes
Other Study ID Numbers: 14547
First Submitted: October 21, 2011
First Posted: October 25, 2011
Last Update Posted: November 7, 2017
Last Verified: March 2017

Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):
Aging

Additional relevant MeSH terms:
Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries