Shoulder DislocationNCT02643537
Associated Pathologies Following Luxatio Erecta Humeri: A Retrospective Analysis of 31 Cases and Diagnostic Algorithm
An observational study of Shoulder Dislocation, run by Medical University of Vienna.
Trial summary
The aim of this study was to evaluate the clinical outcome of this rare injury with special emphasis on associated pathologies. Additionally, we aimed to develop an algorithm for the diagnosis of associated pathologies following LEH. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Dislocation
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Jan 1992to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Included for analysis were thirty-one patients (11 females (average age 68.2 years) and 20 males (average age 48.3 years)) who have been treated for Laxation erecta between 1992 and 2015.
Who may be able to join
- Included for analysis were all patients over 18 years of age who have been treated for LEH between at our department.
Who cannot join
- Only injuries of the affected shoulder were taken into account, non-shoulder related pathologies were not addressed.
- Other types of shoulder dislocation except Luxatio erecta
About this study
The aim of this study was to evaluate the clinical outcome of this rare injury with special emphasis on associated pathologies. Additionally, we aimed to develop an algorithm for the diagnosis of associated pathologies following LEH.
- Conditions
- Shoulder Dislocation
- Medical subject headings
- Shoulder Dislocation
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 |
|---|---|---|
| Luxation erecta | All patients with Inferior shoulder dislocation in fixed abduction, also known as luxatio erecta humeri (LEH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional clinical outcome
Functional outcome (Range of Motion of the shoulder)
Measured: at least 2months
Secondary outcomes (2)
ASSOCIATED PATHOLOGIES
Number of participants with associated pathologies (for example fractures of the greater tuberosity, injuries of the rotator cuff or nerve palsy, e.g.) that were connected with this rare injury
Measured: at least 2 months
Pain
Assessment for pain after operative/conservative therapy with the Visual Analog Score for pain
Measured: at least 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startJan 1992
- Primary completionDec 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 Medical University of ViennaThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julian Joestl, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643537
- Sponsor's protocol ID
- 2009
- Status last verified
- Dec 2015
- First submitted
- 19 Dec 2015
- Last updated
- 31 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associated Pathologies Following Luxatio Erecta Humeri: A Retrospective Analysis of 31 Cases and Diagnostic Algorithm
- ClinicalTrials.gov ID
- NCT02643537
- Acronym / sponsor ID
- 2009
- Conditions
- Shoulder Dislocation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 1992
- Primary completion
- Dec 2015 (actual)
- First posted
- 31 Dec 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.
The aim of this study was to evaluate the clinical outcome of this rare injury with special emphasis on associated pathologies. Additionally, we aimed to develop an algorithm for the diagnosis of associated pathologies following LEH.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Luxation erecta | – | –All patients with Inferior shoulder dislocation in fixed abduction, also known as luxatio erecta humeri (LEH) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Included for analysis were thirty-one patients (11 females (average age 68.2 years) and 20 males (average age 48.3 years)) who have been treated for Laxation erecta between 1992 and 2015.
Key inclusion criteria (1 listed)
- Included for analysis were all patients over 18 years of age who have been treated for LEH between at our department.
Key exclusion criteria (2 listed)
- Only injuries of the affected shoulder were taken into account, non-shoulder related pathologies were not addressed.
- Other types of shoulder dislocation except Luxatio erecta
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
Functional clinical outcome
Time frame: at least 2months
Functional outcome (Range of Motion of the shoulder)
2 secondary outcomes
ASSOCIATED PATHOLOGIES
Time frame: at least 2 months
Pain
Time frame: at least 2 months
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 31 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Dislocation, run by Medical University of Vienna.
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 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 31 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Functional clinical outcome (time frame: at least 2months). 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 31 Dec 2015.