- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01459536
Assessment of Muscle Function and Size in Older Adults With Rotator Cuff Tear (ARC)
November 3, 2017 updated by: Wake Forest University
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
25
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
orthopaedic surgery clinic, community sample
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Rotator Cuff Tear-surgical
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Health Older Adult Control
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Rotator cuff tear - non surgical
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Shoulder strength
Time Frame: baseline
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baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Katherine Saul, PhD, Wake Forest University Health Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
October 21, 2011
First Submitted That Met QC Criteria
October 24, 2011
First Posted (Estimate)
October 25, 2011
Study Record Updates
Last Update Posted (Actual)
November 7, 2017
Last Update Submitted That Met QC Criteria
November 3, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14547
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rotator Cuff Tear
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Bezmialem Vakif UniversityNot yet recruitingRotator Cuff Tears | Partial Tear of Rotator CuffTurkey
-
Keele UniversityUniversity Hospitals, Leicester; Liverpool University Hospitals NHS Foundation... and other collaboratorsWithdrawnTraumatic Rotator Cuff TearUnited Kingdom
-
Rush University Medical CenterSmith & Nephew, Inc.CompletedRotator Cuff Tear Repair Anchors
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University of MichiganCompletedFull Thickness Rotator Cuff Tear
-
Johannes Kepler University of LinzCompletedFull Thickness Rotator Cuff TearAustria
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Lawson Health Research InstituteCompleted
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Orthofix Inc.TerminatedPEMF as Adjunctive Treatment Following Surgical Repair of Full Thickness Rotator Cuff Tears (RCStim)Full-thickness Rotator Cuff TearUnited States
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InGeneron, Inc.CompletedRotator Cuff Tear - Partial ThicknessUnited States
-
Izmir Katip Celebi UniversityTerminatedPartial Thickness Rotator Cuff TearTurkey
-
BioMimetic TherapeuticsCompletedFull Thickness Rotator Cuff TearCanada