Shoulder DislocationNCT00707018
Immobilization in External Rotation After First Time Anterior Shoulder Dislocation
A study testing External rotation shoulder sling and Internal rotation shoulder sling in people with Shoulder Dislocation, run by University of Colorado, Denver at 8 sites in United States.
Trial summary
Comparison of immobilization in internal versus external rotation after first time anterior shoulder dislocation. Read more about this study
- Who is it for?
- Ages 14 to 30 years
- Conditions the study is for
- Shoulder Dislocation
- What is being tested?
- External rotation shoulder sling and Internal rotation shoulder sling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 8 sitesUnited States
- Study dates
- Sep 2004to Feb 2012
- Phase
- Interventional
- 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 14 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 14 to 30 years of age
- Willing to participate in follow-up for at least two years
- Acute, first-time, traumatic, isolated anterior dislocation of the shoulder
Who cannot join
- Previous instability of the affected shoulder
- A history of significant ligamentous laxity or demonstrated multi-directional instability of the opposite shoulder
- Inability or unwillingness to comply with sling immobilization, rehabilitative protocol, or required follow-up assessments
- Incompetent or unwilling to consent
- A medical condition making the patient unable to wear a sling
- Significant associated fracture (Exception Hill Sachs of >20% or bony Bankart lesions>10%)
- Neurovascular compromise of the affected limb
- Concomitant ipsilateral upper extremity injuries which may affect the patient's ability to participate in, or benefit from, a rehabilitative program.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Summa Healthcare
Akron, Ohio, 44310
University of New Mexico
Albuquerque, New Mexico, 87131
CU Sports Medicine
Boulder, Colorado, 80304
Ohio State University
Columbus, Ohio, 43221
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Vanderbilt University
Nashville, Tennessee, 37212
Inland Orthopaedics
Pullman, Washington, 99163
St. Anthony Hospitals
Winter Park, Colorado, 80482
About this study
Official title: Immobilization in External Rotation After First Time Anterior Shoulder Dislocation: A Prospective Randomized Study
Comparison of immobilization in internal versus external rotation after first time anterior shoulder dislocation.
Read the detailed description
The purpose of this study is to compare immobilization in internal versus external rotation after first time anterior shoulder dislocation, and thereby increase our knowledge about the best standard of care.
- Conditions
- Shoulder Dislocation
- Being tested
- External rotation shoulder sling, Internal rotation shoulder sling
- Medical subject headings
- Shoulder Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External rotation shoulder slingDevice
The external rotation sling will be adjusted to position the injured upper extremity in 90 degrees of elbow flexion, 0 degrees of shoulder abduction and flexion, and 10 to 15 degrees of external rotation at the shoulder.
Internal rotation shoulder slingDevice
The internal rotation sling will be adjusted to position the injured upper extremity in 90 degrees of elbow flexion, 0 degrees of shoulder abduction and flexion, and 70 to 80 degrees of internal rotation at the shoulder.
| Study group | Role | What they receive |
|---|---|---|
| External rotation shoulder sling | Experimental | External rotation shoulder sling Receives: Device: External rotation shoulder sling |
| Internal rotation shoulder sling | Active comparator | Internal rotation shoulder sling Receives: Device: Internal rotation shoulder sling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent instability consisting of a documented episode of anterior shoulder dislocation or multiple episodes of shoulder subluxation.
Measured: 24 months
Secondary outcomes (2)
Patient self reported outcome measures
Measured: 24 Months
Time to return to work or sport
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2008 (estimated)
- Study startSep 2004
- Primary completionFeb 2012
- Study completionFeb 2012
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 Colorado, DenverThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric C McCarty, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00707018
- Sponsor's protocol ID
- 04-0088
- Status last verified
- Apr 2019
- First submitted
- 26 Jun 2008
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immobilization in External Rotation After First Time Anterior Shoulder Dislocation: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT00707018
- Acronym / sponsor ID
- 04-0088
- Conditions
- Shoulder Dislocation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 30 Jun 2008 (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.
Comparison of immobilization in internal versus external rotation after first time anterior shoulder dislocation.
Detailed description
The purpose of this study is to compare immobilization in internal versus external rotation after first time anterior shoulder dislocation, and thereby increase our knowledge about the best standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External rotation shoulder sling | Experimental | Device: External rotation shoulder slingExternal rotation shoulder sling |
| Internal rotation shoulder sling | Active comparator | Device: Internal rotation shoulder slingInternal rotation shoulder sling |
Who may qualify
- Ages
- 14 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 14 to 30 years of age
- Willing to participate in follow-up for at least two years
- Acute, first-time, traumatic, isolated anterior dislocation of the shoulder
Key exclusion criteria (8 listed)
- Previous instability of the affected shoulder
- A history of significant ligamentous laxity or demonstrated multi-directional instability of the opposite shoulder
- Inability or unwillingness to comply with sling immobilization, rehabilitative protocol, or required follow-up assessments
- Incompetent or unwilling to consent
- A medical condition making the patient unable to wear a sling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External rotation shoulder slingThe external rotation sling will be adjusted to position the injured upper extremity in 90 degrees of elbow flexion, 0 degrees of shoulder abduction and flexion, and 10 to 15 degrees of external rotation at the shoulder. | Device | External rotation shoulder sling |
| Internal rotation shoulder slingThe internal rotation sling will be adjusted to position the injured upper extremity in 90 degrees of elbow flexion, 0 degrees of shoulder abduction and flexion, and 70 to 80 degrees of internal rotation at the shoulder. | Device | Internal rotation shoulder sling |
Primary outcome
Recurrent instability consisting of a documented episode of anterior shoulder dislocation or multiple episodes of shoulder subluxation.
Time frame: 24 months
2 secondary outcomes
Patient self reported outcome measures
Time frame: 24 Months
Time to return to work or sport
Time frame: 24 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 18 Apr 2019.
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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.
Eric C McCarty, MD principal investigator
University of Colorado, Denver
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External rotation shoulder sling and Internal rotation shoulder sling in people with Shoulder Dislocation, run by University of Colorado, Denver at 8 sites 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 3 inclusion and 8 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 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Recurrent instability consisting of a documented episode of anterior shoulder dislocation or multiple episodes of shoulder subluxation. (time frame: 24 months). 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 18 Apr 2019.