Rotator Cuff TearARCNCT01459536
Assessment of Muscle Function and Size in Older Adults With Rotator Cuff Tear
An observational study of Rotator Cuff Tear, run by Wake Forest University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tear
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: orthopaedic surgery clinic, community sample
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
- Conditions
- Rotator Cuff Tear
- Keywords
- Aging
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rotator Cuff Tear-surgical | Not described | |
| Health Older Adult Control | Not described | |
| Rotator cuff tear - non surgical | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder strength
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine Saul, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459536
- Sponsor's protocol ID
- 14547
- Acronym
- ARC
- Status last verified
- Mar 2017
- First submitted
- 21 Oct 2011
- Last updated
- 7 Nov 2017
- Results posted
- No
Publications
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.
PubMed 26391648
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotator Cuff Function and Muscle Morphology in Older Adults With Rotator Cuff Tear
- ClinicalTrials.gov ID
- NCT01459536
- Acronym / sponsor ID
- ARC / 14547
- Conditions
- Rotator Cuff Tear
- Keywords
- Aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 25 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rotator Cuff Tear-surgical | – | – |
| Health Older Adult Control | – | – |
| Rotator cuff tear - non surgical | – | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- orthopaedic surgery clinic, community sample
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Shoulder strength
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Derived from this study: PubMed 26391648Vidt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Saul, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tear, run by Wake Forest University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder strength (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01459536, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017.