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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Katherine Saul, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT01459536
First received: October 21, 2011
Last updated: March 16, 2017
Last verified: March 2017

October 21, 2011
March 16, 2017
September 2011
December 2013   (Final data collection date for primary outcome measure)
Shoulder strength [ Time Frame: baseline ]
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Complete list of historical versions of study NCT01459536 on ClinicalTrials.gov Archive Site
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Assessment of Muscle Function and Size in Older Adults With Rotator Cuff Tear
Rotator Cuff Function and Muscle Morphology 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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Observational
Observational Model: Case-Control
Time Perspective: Prospective
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Non-Probability Sample
orthopaedic surgery clinic, community sample
Rotator Cuff Tear
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  • Rotator Cuff Tear-surgical
  • Health Older Adult Control
  • Rotator cuff tear - non surgical
Vidt ME, Santago AC 2nd, Tuohy CJ, Poehling GG, Freehill MT, Kraft RA, Marsh AP, Hegedus EJ, Miller ME, Saul KR. Assessments of Fatty Infiltration and Muscle Atrophy From a Single Magnetic Resonance Image Slice Are Not Predictive of 3-Dimensional Measurements. Arthroscopy. 2016 Jan;32(1):128-39. doi: 10.1016/j.arthro.2015.06.035. Epub 2015 Sep 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
December 2013
December 2013   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
60 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01459536
14547
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Katherine Saul, Wake Forest University Health Sciences
Wake Forest University
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Principal Investigator: Katherine Saul, PhD Wake Forest University Health Sciences
Wake Forest University Health Sciences
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP