Rotator Cuff TearNCT01242761
Ultrasound as a Diagnostic Tool for Rotator Cuff Tears
An observational study of Rotator Cuff Tear, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
After comparing ultrasound study of rotator cuff injuries that have been evaluated both in the community and in a hospital-based ultrasound service with actual surgical findings, it is expected that specialist performed imaging and evaluation will be most accurate and that those performed in the community will be not… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rotator Cuff Tear
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to Jan 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with symptomatic rotator cuff tears
Who may be able to join
- Symptomatic rotator cuff tears Indication for rotator cuff repair
Who cannot join
- Severe arm movement limitations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound as a Diagnostic Tool for Rotator Cuff Tears: Accuracy of Results From the Community Versus Results From a Hospital-based Ultrasound Service and Surgical Findings
After comparing ultrasound study of rotator cuff injuries that have been evaluated both in the community and in a hospital-based ultrasound service with actual surgical findings, it is expected that specialist performed imaging and evaluation will be most accurate and that those performed in the community will be not accurate enough.
- Conditions
- Rotator Cuff Tear
- Keywords
- Accuracy of diagnostic ultrasound based in community or as part of a specialist hospital-based service
- 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 |
|---|---|---|
| Symptomatic rotator cuff tear | Patients with symptomatic rotator cuff tears presenting to hospital clinic after having ultrasound exam in community with indications for surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rotator cuff tear surgical findings more accurately reflect hospital-based US imaging findings
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionJan 2012 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242761
- Sponsor's protocol ID
- 0092-10-HYMC
- Status last verified
- Nov 2010
- First submitted
- 16 Nov 2010
- Last updated
- 17 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound as a Diagnostic Tool for Rotator Cuff Tears: Accuracy of Results From the Community Versus Results From a Hospital-based Ultrasound Service and Surgical Findings
- ClinicalTrials.gov ID
- NCT01242761
- Acronym / sponsor ID
- 0092-10-HYMC
- Conditions
- Rotator Cuff Tear
- Keywords
- Accuracy of diagnostic ultrasound based in community or as part of a specialist hospital-based service
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 17 Nov 2010 (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.
After comparing ultrasound study of rotator cuff injuries that have been evaluated both in the community and in a hospital-based ultrasound service with actual surgical findings, it is expected that specialist performed imaging and evaluation will be most accurate and that those performed in the community will be not accurate enough.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptomatic rotator cuff tear | – | –Patients with symptomatic rotator cuff tears presenting to hospital clinic after having ultrasound exam in community with indications for surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with symptomatic rotator cuff tears
Key inclusion criteria (1 listed)
- Symptomatic rotator cuff tears Indication for rotator cuff repair
Key exclusion criteria (1 listed)
- Severe arm movement limitations
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
Rotator cuff tear surgical findings more accurately reflect hospital-based US imaging findings
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2010.
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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.
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 Hillel Yaffe Medical Center at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 17 Nov 2010. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gil Laufer, MD (972-4-630-4160, GilL@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rotator cuff tear surgical findings more accurately reflect hospital-based US imaging findings (time frame: One 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 17 Nov 2010.