Stability of Clavicular Fractures Within the First 3 WeeksNCT02089282
Clavicular Shortening Post-fracture - Does it Change? - a Prospective Study of 70 Patients
An observational study of Stability of Clavicular Fractures Within the First 3 Weeks, run by Holbaek Sygehus at 1 site in Denmark.
Trial summary
In an attempt to answer if clavicular length changes after a fracture e.g. that any shortening becomes worse or better, 70 patients will be followed 3 times over 21 days using a novel ultrasound method. Read more about this study
- Who is it for?
- Ages 17 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Stability of Clavicular Fractures Within the First 3 Weeks
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2014to Aug 2014
- How long will I take part?
- 21 Days
- 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 17 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Clavicular fractures
Who may be able to join
- All patients who sustain a displaced medial, mid and lateral clavicle fracture from March 2014 to August 2015 referred from Slagelse and Holbæk emergency departments are eligible. The last patients are seen end of mid-July 2015 given the 21 days of follow up.
Who cannot join
- Patients that have bilateral clavicle fractures and/or prior operations involving the clavicle are excluded. Malignant diagnoses are excluded.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Holbæk sygehus
Holbæk, Vest-sjælland, 4300
Anders Thorsmark Høj, MD, + 45 5948000
Anders Thorsmark Høj, MD, +45 59484000, athh@regionsjaelland.dk
About this study
In an attempt to answer if clavicular length changes after a fracture e.g. that any shortening becomes worse or better, 70 patients will be followed 3 times over 21 days using a novel ultrasound method.
- Being tested
- Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
| Study group | Role | What they receive |
|---|---|---|
| Clavicle fractures | Not described Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clavicular length
The dynamic testing of clavicular length and when or which fracures that are stabile.
Measured: 3 weeks
Secondary outcomes (1)
Oxford shoulder score
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stability of Clavicular Fractures Within the First 3 WeeksStudies 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
- 70 participants (estimated)
- Target duration
- 21 Days
Sponsor and investigators
- Lead sponsor
- Holbaek Sygehus
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089282
- Sponsor's protocol ID
- SJ-369
- Status last verified
- Mar 2014
- First submitted
- 14 Mar 2014
- Last updated
- 17 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clavicular Shortening Post-fracture - Does it Change? - a Prospective Study of 70 Patients
- ClinicalTrials.gov ID
- NCT02089282
- Acronym / sponsor ID
- SJ-369
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Holbaek SygehusUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- Mar 2014
- Primary completion
- Aug 2014 (estimated)
- First posted
- 17 Mar 2014 (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.
In an attempt to answer if clavicular length changes after a fracture e.g. that any shortening becomes worse or better, 70 patients will be followed 3 times over 21 days using a novel ultrasound method.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 21 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clavicle fractures | – | Device: Ultrasound |
Who may qualify
- Ages
- 17 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Clavicular fractures
Key inclusion criteria (1 listed)
- All patients who sustain a displaced medial, mid and lateral clavicle fracture from March 2014 to August 2015 referred from Slagelse and Holbæk emergency departments are eligible. The last patients are seen end of mid-July 2015 given the 21 days of follow up.
Key exclusion criteria (1 listed)
- Patients that have bilateral clavicle fractures and/or prior operations involving the clavicle are excluded. Malignant diagnoses are excluded.
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 |
|---|---|---|
| Ultrasound | Device | Clavicle fractures |
Primary outcome
Change in clavicular length
Time frame: 3 weeks
The dynamic testing of clavicular length and when or which fracures that are stabile.
1 secondary outcome
Oxford shoulder score
Time frame: 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2014.
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 Stability of Clavicular Fractures Within the First 3 Weeks, run by Holbaek Sygehus at 1 site in Denmark.
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 Mar 2014. 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 Denmark. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in clavicular length (time frame: 3 weeks). 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 Mar 2014.