Shoulder DislocationNCT02469818
Diagnostic Accuracy of Bedside Ultrasonography in the Management of the Shoulder Dislocations
An observational study of Shoulder Dislocation, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Shoulder dislocation is a common clinical presentation in the emergency department, comprising about 50 percent of all major joint dislocations. In the standart management of shoulder dislocations physicians generally need to see pre and post reduction x ray graphics. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Shoulder Dislocation
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2015to Aug 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients over 14 years of age with the complaint of shoulder pain and suspected glenohumeral dislocations
Who may be able to join
- All patients over 14 years with suspected shoulder dislocation
- Accept to be participating
Who cannot join
- Patients under 15 years of age
- Diagnosed before pocus evaluation
- Open fracture dislocations of the shoulder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Can K. Akyol
Antalya, 07070
Mustafa Kesapli, MD, +905325239901, mustafakesapli@hotmail.com
A. Janitzky
About this study
Official title: Diagnostic Accuracy of Bedside Point of Care Ulrasound (POCUS) in the Management of the Shoulder Dislocations
Shoulder dislocation is a common clinical presentation in the emergency department, comprising about 50 percent of all major joint dislocations. In the standart management of shoulder dislocations physicians generally need to see pre and post reduction x ray graphics. Ultrasonography is harmless way of evaluating shoulder and may be used in the management of the shoulder dislocations instead of the x ray evaluations.
Read the detailed description
Shoulder dislocation is a common clinical presentation in the emergency department, comprising about 50 percent of all major joint dislocations. In the standard management of shoulder dislocations physicians generally need to see pre and post reduction x ray graphics. Ultrasonography is harmless way of evaluating shoulder and may be used in the management of the shoulder dislocations instead of the x ray evaluations.Recent literature has demonstrated the superiority of point-of-care ultrasonography (POCUS) in detecting both anterior and posterior shoulder dislocations, making it another rapidly evolving tool to improve accuracy, decrease error, and improve efficiency. The aim of the study is to evaluate the accuracy and clinical usability of ultrasonography in the management of the shoulder dislocations.
- Conditions
- Shoulder Dislocation
- Keywords
- pocus, ultrasonography, glenohumeral dislocation
- Medical subject headings
- Shoulder Dislocation
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of emergency physician performed point of care ultrasonography of shoulder in diagnosing of shoulder dislocations
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 posted12 Jun 2015 (estimated)
- Study startJan 2015
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Shoulder DislocationStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Can K. Akyol, MD, Principal investigator, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469818
- Sponsor's protocol ID
- AntalyaTRH005
- Status last verified
- Jun 2015
- First submitted
- 8 Jun 2015
- Last updated
- 16 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Abbasi S, Molaie H, Hafezimoghadam P, Zare MA, Abbasi M, Rezai M, Farsi D. Diagnostic accuracy of ultrasonographic examination in the management of shoulder dislocation in the emergency department. Ann Emerg Med. 2013 Aug;62(2):170-5. doi: 10.1016/j.annemergmed.2013.01.022. Epub 2013 Mar 13.
PubMed 23489654Mackenzie DC, Liebmann O. Point-of-care ultrasound facilitates diagnosing a posterior shoulder dislocation. J Emerg Med. 2013 May;44(5):976-8. doi: 10.1016/j.jemermed.2012.11.080. Epub 2013 Mar 13.
PubMed 23490112Kahn JH, Mehta SD. The role of post-reduction radiographs after shoulder dislocation. J Emerg Med. 2007 Aug;33(2):169-73. doi: 10.1016/j.jemermed.2007.01.003. Epub 2007 Jun 13.
PubMed 17692769Hendey GW. Necessity of radiographs in the emergency department management of shoulder dislocations. Ann Emerg Med. 2000 Aug;36(2):108-113. doi: 10.1067/mem.2000.108314.
PubMed 10918101Gupta H, Robinson P. Normal shoulder ultrasound: anatomy and technique. Semin Musculoskelet Radiol. 2015 Jul;19(3):203-11. doi: 10.1055/s-0035-1549315. Epub 2015 May 28.
PubMed 26021582Smith MJ, Rogers A, Amso N, Kennedy J, Hall A, Mullaney P. A training, assessment and feedback package for the trainee shoulder sonographer. Ultrasound. 2015 Feb;23(1):29-41. doi: 10.1177/1742271X14566067.
PubMed 25866545Akyol C, Gungor F, Akyol AJ, Kesapli M, Guven R, Cengiz U, Toksul HI, Eken C. Point-of-care ultrasonography for the management of shoulder dislocation in ED. Am J Emerg Med. 2016 May;34(5):866-70. doi: 10.1016/j.ajem.2016.02.006. Epub 2016 Feb 16.
PubMed 26935225
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Bedside Point of Care Ulrasound (POCUS) in the Management of the Shoulder Dislocations
- ClinicalTrials.gov ID
- NCT02469818
- Acronym / sponsor ID
- AntalyaTRH005
- Conditions
- Shoulder Dislocation
- Keywords
- pocus, ultrasonography, glenohumeral dislocation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- Jan 2015
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 12 Jun 2015 (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.
Shoulder dislocation is a common clinical presentation in the emergency department, comprising about 50 percent of all major joint dislocations. In the standart management of shoulder dislocations physicians generally need to see pre and post reduction x ray graphics. Ultrasonography is harmless way of evaluating shoulder and may be used in the management of the shoulder dislocations instead of the x ray evaluations.
Detailed description
Shoulder dislocation is a common clinical presentation in the emergency department, comprising about 50 percent of all major joint dislocations. In the standard management of shoulder dislocations physicians generally need to see pre and post reduction x ray graphics. Ultrasonography is harmless way of evaluating shoulder and may be used in the management of the shoulder dislocations instead of the x ray evaluations.Recent literature has demonstrated the superiority of point-of-care ultrasonography (POCUS) in detecting both anterior and posterior shoulder dislocations, making it another rapidly evolving tool to improve accuracy, decrease error, and improve efficiency. The aim of the study is to evaluate the accuracy and clinical usability of ultrasonography in the management of the shoulder dislocations.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients over 14 years of age with the complaint of shoulder pain and suspected glenohumeral dislocations
Key inclusion criteria (2 listed)
- All patients over 14 years with suspected shoulder dislocation
- Accept to be participating
Key exclusion criteria (3 listed)
- Patients under 15 years of age
- Diagnosed before pocus evaluation
- Open fracture dislocations of the shoulder
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
Diagnostic accuracy of emergency physician performed point of care ultrasonography of shoulder in diagnosing of shoulder dislocations
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2015.
- Background: PubMed 23489654Abbasi S, Molaie H, Hafezimoghadam P, Zare MA, Abbasi M, Rezai M, Farsi D. Diagnostic accuracy of ultrasonographic examination in the management of shoulder dislocation in the emergency department. Ann Emerg Med. 2013 Aug;62(2):170-5. doi: 10.1016/j.annemergmed.2013.01.022. Epub 2013 Mar 13.
- Background: PubMed 23490112Mackenzie DC, Liebmann O. Point-of-care ultrasound facilitates diagnosing a posterior shoulder dislocation. J Emerg Med. 2013 May;44(5):976-8. doi: 10.1016/j.jemermed.2012.11.080. Epub 2013 Mar 13.
- Background: PubMed 17692769Kahn JH, Mehta SD. The role of post-reduction radiographs after shoulder dislocation. J Emerg Med. 2007 Aug;33(2):169-73. doi: 10.1016/j.jemermed.2007.01.003. Epub 2007 Jun 13.
- Background: PubMed 10918101Hendey GW. Necessity of radiographs in the emergency department management of shoulder dislocations. Ann Emerg Med. 2000 Aug;36(2):108-113. doi: 10.1067/mem.2000.108314.
- Background: PubMed 26021582Gupta H, Robinson P. Normal shoulder ultrasound: anatomy and technique. Semin Musculoskelet Radiol. 2015 Jul;19(3):203-11. doi: 10.1055/s-0035-1549315. Epub 2015 May 28.
- Background: PubMed 25866545Smith MJ, Rogers A, Amso N, Kennedy J, Hall A, Mullaney P. A training, assessment and feedback package for the trainee shoulder sonographer. Ultrasound. 2015 Feb;23(1):29-41. doi: 10.1177/1742271X14566067.
- Derived from this study: PubMed 26935225Akyol C, Gungor F, Akyol AJ, Kesapli M, Guven R, Cengiz U, Toksul HI, Eken C. Point-of-care ultrasonography for the management of shoulder dislocation in ED. Am J Emerg Med. 2016 May;34(5):866-70. doi: 10.1016/j.ajem.2016.02.006. Epub 2016 Feb 16.
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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.
Can K. Akyol, MD principal investigator
Antalya Training and Research Hospital
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 Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 3 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 16 Jun 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 Turkey (Türkiye). 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 Can K. Akyol, MD (+905324941070, drcanakyol@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of emergency physician performed point of care ultrasonography of shoulder in diagnosing of shoulder dislocations (time frame: 1 year). 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 NCT02469818, which also lists 7 linked publications.
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 16 Jun 2015.