Clavicle FractureNCT03402269
Treatment of Pediatric Mid-shaft Clavicle Fractures: A Prospective, Observational Study
An observational study of Clavicle Fracture and Adolescent, run by Prisma Health-Upstate at 1 site in United States.
Trial summary
Clavicle fractures in children are common. Typical treatment includes nonoperative treatment with a sling. Operative treatment is usually limited to open, unstable, fractures with either epidermal risks or neurovascular compromise. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Clavicle Fracture, Adolescent
- What is being tested?
- Clavicle fracture injury- observation
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2018to 31 Dec 2022
- 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 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: 11-17 years old with displaced fractures of the middle third of the clavicle
Who may be able to join
- 11-17 years old with fractures of the middle third of the clavicle
- Displaced 100% the width of the clavicle or shortened 1 centimeter
- Operative and non-operative treated clavicles will be eligible for enrollment
Who cannot join
- Open clavicle fractures
- Ipsilateral shoulder injuries
- Fractures involving the lateral ligaments or the sternoclavicular joint
- Bilateral clavicle fractures
- Pathologic fractures
- Refractures
Show all 10Show fewer
- Fractures with neurovascular compromise
- Displaced fractures with impending skin compromise
- If there has been more than 21 days between injury and enrollment
- Patients with cognitive disabilities that inhibit the completion of the questionnaires
Trial locations and contacts
1 site in 1 country.
United States1 site
Greenville Hospital System
Greenville, South Carolina, 29605
About this study
Clavicle fractures in children are common. Typical treatment includes nonoperative treatment with a sling. Operative treatment is usually limited to open, unstable, fractures with either epidermal risks or neurovascular compromise. Orthopaedic literature has many studies that report the need for additional research for this prevalent fracture. This is an observational study evaluating the functional and patient reported outcomes of displaced clavicle fractures in adolescents. The results from this study will help the orthopedist understand the expected outcomes for a given pediatric patient with a clavicle fracture.
- Conditions
- Clavicle Fracture, Adolescent
- Being tested
- Clavicle fracture injury- observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clavicle fracture injury- observationOther
The study is an observational study with assessments at 1 month, 3 months, 6 months and 1 year following injury. Assessments include range of motion, strength, patient reported outcomes and radiographic healing
| Study group | Role | What they receive |
|---|---|---|
| Adolescents with displaced clavicle fractures | Adolescents (11 to 17 years old) with displaced clavicle fractures will be enrolled in this study. Receives: Other: Clavicle fracture injury- observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion
Range of motion measured by goniometer
Measured: at 1 year post injury
Radiographic healing
Radiographic evidence of healing on 3 of 4 cortices
Measured: at 1 year post injury
Secondary outcomes (2)
QuickDash
QuickDash Outcome Measure- measuring patient reported disability of arm, shoulder and hand
Measured: at 3 months, 6 months and 12 months
PODCI
Adolescent Pediatric Outcomes Data Collection Instrument - measuring patient reported outcomes in a pediatric population
Measured: at 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start10 Jan 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clavicle FractureStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher C Bray, MD, Principal investigator, Prisma Health-Upstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402269
- Sponsor's protocol ID
- Pro00066019
- Status last verified
- Mar 2023
- First submitted
- 10 Jan 2018
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Pediatric Mid-shaft Clavicle Fractures: A Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT03402269
- Acronym / sponsor ID
- Pro00066019
- Conditions
- Clavicle Fracture, Adolescent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 18 Jan 2018 (actual)
- 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.
Clavicle fractures in children are common. Typical treatment includes nonoperative treatment with a sling. Operative treatment is usually limited to open, unstable, fractures with either epidermal risks or neurovascular compromise. Orthopaedic literature has many studies that report the need for additional research for this prevalent fracture. This is an observational study evaluating the functional and patient reported outcomes of displaced clavicle fractures in adolescents. The results from this study will help the orthopedist understand the expected outcomes for a given pediatric patient with a clavicle fracture.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents with displaced clavicle fractures | – | Other: Clavicle fracture injury- observationAdolescents (11 to 17 years old) with displaced clavicle fractures will be enrolled in this study. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 11-17 years old with displaced fractures of the middle third of the clavicle
Key inclusion criteria (3 listed)
- 11-17 years old with fractures of the middle third of the clavicle
- Displaced 100% the width of the clavicle or shortened 1 centimeter
- Operative and non-operative treated clavicles will be eligible for enrollment
Key exclusion criteria (10 listed)
- Open clavicle fractures
- Ipsilateral shoulder injuries
- Fractures involving the lateral ligaments or the sternoclavicular joint
- Bilateral clavicle fractures
- Pathologic fractures
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 |
|---|---|---|
| Clavicle fracture injury- observationThe study is an observational study with assessments at 1 month, 3 months, 6 months and 1 year following injury. Assessments include range of motion, strength, patient reported outcomes and radiographic healing | Other | Adolescents with displaced clavicle fractures |
Primary outcome
Range of motion
Time frame: at 1 year post injury
Range of motion measured by goniometer
Radiographic healing
Time frame: at 1 year post injury
Radiographic evidence of healing on 3 of 4 cortices
2 secondary outcomes
QuickDash
Time frame: at 3 months, 6 months and 12 months
PODCI
Time frame: at 3 months, 6 months and 12 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 28 Mar 2023.
- Individual participant dataSharing planned: No. There are no plans to share IPD
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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.
Christopher C Bray, MD principal investigator
Prisma Health-Upstate
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 Clavicle Fracture and Adolescent, run by Prisma Health-Upstate at 1 site 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 10 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 28 Mar 2023. 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 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?
Range of motion (time frame: at 1 year post injury). The study lists 2 primary outcomes in all. 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 28 Mar 2023.