Clinical trial NCT01459536: Assessment of Muscle Function and Size in Older Adults With Rotator Cuff Tear
Official title: Rotator Cuff Function and Muscle Morphology in Older Adults With Rotator Cuff Tear
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Tear
Keywords: Aging
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2011-10-25
Enrollment: 25
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: orthopaedic surgery clinic, community sample

Brief 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.


Eligibility 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)

Primary outcomes:
measure: Shoulder strength
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Katherine Saul, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.