NCT01459536

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 25, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

November 7, 2017

Status Verified

March 1, 2017

Enrollment Period

2.3 years

First QC Date

October 21, 2011

Last Update Submit

November 3, 2017

Conditions

Keywords

Aging

Outcome Measures

Primary Outcomes (1)

  • Shoulder strength

    baseline

Study Arms (3)

Rotator Cuff Tear-surgical

Health Older Adult Control

Rotator cuff tear - non surgical

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

orthopaedic surgery clinic, community sample

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Officials

  • Katherine Saul, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2011

First Posted

October 25, 2011

Study Start

September 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

November 7, 2017

Record last verified: 2017-03

Locations