Shoulder DislocationNCT01549912
Results of Rotator Cuff Repair
An observational study of Shoulder Dislocation, run by University of Utah at 1 site in United States.
Trial summary
The primary objective of this research is to examine the result of rotator cuff repairs following acute shoulder dislocations and to investigate whether timing of surgery following acute shoulder dislocations affects patients perception of pain, function, and strength following surgery. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shoulder Dislocation
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Apr 2015
- 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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population will include patients age 35 years and older who have sustained an acute rotator cuff tear following shoulder dislocation who underwent a rotator cuff repair either by open or arthroscopic techniques between January 1, 2001 and June 1, 2011.
Who may be able to join
- age 35 years or older with acute rotator cuff tear following documented shoulder dislocation requiring reduction, subjects sustained acute rotator cuff tear following shoulder dislocation that was treated surgically with open and/or arthroscopic technique between January 1, 2001 and June 1, 2011, surgical intervention within 6 months of dislocation, minimum follow up time of one year from surgery.
Who cannot join
- rotator cuff tears without shoulder dislocation, known previous rotator cuff disease, history of other trauma to the shoulder, inability to provide informed consent, other suspect pathology (ie: tumor, infection).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Results of Rotator Cuff Repair Following Acute Shoulder Dislocation
The primary objective of this research is to examine the result of rotator cuff repairs following acute shoulder dislocations and to investigate whether timing of surgery following acute shoulder dislocations affects patients perception of pain, function, and strength following surgery.
Read the detailed description
There is a higher risk of rotator cuff tears following dislocation when the individual is greater than 40 years old. Rotator cuff tears after dislocation of the shoulder are more of a challenge to repair particularly if there is a delay in diagnosis. Clinical experience would suggest that rotator cuff repair within the first month of injury allows for better results in acute rotator cuff tears without shoulder dislocation. There are no reported results for rotator cuff repairs following shoulder dislocation and timing of repair. If we find that early repair provides better results this will be important for Primary Care Providers and Emergency Department physicians to refer these patients early for evaluation and subsequently earlier treatment.
- Conditions
- Shoulder Dislocation
- Keywords
- Rotator Cuff Tears, Dislocation, Shoulder Dislocation
- Medical subject headings
- Shoulder Dislocation, Rotator Cuff Injuries, Joint Dislocations
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 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of pain, range of motion and strength
Patient are asked to complete ASES, SST, SF-12 questionaires. Clinical evaluation of bilateral range of motion and strength measurements.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder DislocationStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Tashjian, University of Utah
- Investigators
- Robert Z Tashjian, MD, Principal investigator, University of Utah Orthopaedic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01549912
- Sponsor's protocol ID
- 54314
- Status last verified
- Aug 2015
- First submitted
- 6 Mar 2012
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of Rotator Cuff Repair Following Acute Shoulder Dislocation
- ClinicalTrials.gov ID
- NCT01549912
- Acronym / sponsor ID
- 54314
- Conditions
- Shoulder Dislocation
- Keywords
- Rotator Cuff Tears, Dislocation, Shoulder Dislocation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 9 Mar 2012 (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.
The primary objective of this research is to examine the result of rotator cuff repairs following acute shoulder dislocations and to investigate whether timing of surgery following acute shoulder dislocations affects patients perception of pain, function, and strength following surgery.
Detailed description
There is a higher risk of rotator cuff tears following dislocation when the individual is greater than 40 years old. Rotator cuff tears after dislocation of the shoulder are more of a challenge to repair particularly if there is a delay in diagnosis. Clinical experience would suggest that rotator cuff repair within the first month of injury allows for better results in acute rotator cuff tears without shoulder dislocation. There are no reported results for rotator cuff repairs following shoulder dislocation and timing of repair. If we find that early repair provides better results this will be important for Primary Care Providers and Emergency Department physicians to refer these patients early for evaluation and subsequently earlier treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rotator cuff tear | – | – |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will include patients age 35 years and older who have sustained an acute rotator cuff tear following shoulder dislocation who underwent a rotator cuff repair either by open or arthroscopic techniques between January 1, 2001 and June 1, 2011.
Key inclusion criteria (1 listed)
- age 35 years or older with acute rotator cuff tear following documented shoulder dislocation requiring reduction, subjects sustained acute rotator cuff tear following shoulder dislocation that was treated surgically with open and/or arthroscopic technique between January 1, 2001 and June 1, 2011, surgical intervention within 6 months of dislocation, minimum follow up time of one year from surgery.
Key exclusion criteria (1 listed)
- rotator cuff tears without shoulder dislocation, known previous rotator cuff disease, history of other trauma to the shoulder, inability to provide informed consent, other suspect pathology (ie: tumor, infection).
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
Levels of pain, range of motion and strength
Time frame: 1 year
Patient are asked to complete ASES, SST, SF-12 questionaires. Clinical evaluation of bilateral range of motion and strength measurements.
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 6 Aug 2015.
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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.
Robert Z Tashjian, MD principal investigator
University of Utah Orthopaedic
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 Shoulder Dislocation, run by University of Utah 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 1 inclusion and 1 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 6 Aug 2015. 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?
Levels of pain, range of motion and strength (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2015.