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Completed

NCT Number: NCT01459536

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Shoulder strength

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

Wake Forest University

Other

Registry information

Official study title

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

Acronym: ARC

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 25, 2011
Registry last updated
Nov 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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