Radial FractureNCT03360318
Brace Versus Casting in Pediatric Radial Head Fractures
A study testing elbow cast and Removable elbow brace in people with Radial Fracture, run by Peking University People's Hospital at 1 site in China.
Trial summary
Commare the pain and function of Brace Versus Casting in Pediatric Radial Head Fractures after 1 month Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Radial Fracture
- What is being tested?
- elbow cast and Removable elbow brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2018to 5 Feb 2019
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 5 to 18 years of age with one of the following fracture Undisplaced Maoson types I and II fractures of the radial head
Who cannot join
- The diagnosis of elbow sprain or contusion; they occur primarily in adolescents with closed epiphyseal plates.
- All open fractures which require surgical debridement. All children at risk for pathological fractures such as those with congenital or acquired generalized bony disease.
- Congenital anomalies of the elbow. Patients with coagulopathies. Multisystem trauma and multiple fractures of the same or opposite limb. Patients cognitively and developmentally delayed with inability to express pain and/or difficult assessment of baseline activity level.
- Injuries greater than 72 hours old. Past history of surgery or closed reduction of the same elbow within the last 6 months or ankle trauma of the same ankle within 3 months.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Peixun Zhang, Doctor, 08613611237628, zhangpeixun@163.com
Yichong Zhang, Doctor, 08601088326550, zhangyichong@163.com
About this study
Commare the pain and function of Brace Versus Casting in Pediatric Radial Head Fractures after 1 month
Read the detailed description
Radial Head Fractures are common injury in children. In this study, healthy children with Mason type I or II radial head fractures are planned to be included.
Outcome Measures: The primary outcome measure will be an assessment of functional daily activities as measured by the MAYO score at four weeks post injury. Secondary outcomes will include an assessment of pain scores using VAS.
Sample Size and Analysis: Assuming a standard deviation of 10%, alpha = 0.05, beta = 0.2 and 10% dropout rate yields a sample size of 150 patients. Secondary analyses will include Fisher's Exact test to compare proportions of children with full range of motion of the injured ankle at four weeks and with full baseline activity level at four months, and the area under the curve of a pain-time profile curve will be compared using a Student's t-test.
- Conditions
- Radial Fracture
- Being tested
- elbow cast, Removable elbow brace
- Keywords
- pediatric, elbow fractures, management
- Medical subject headings
- Radius Fractures, Elbow Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elbow castDevice
elbow cast
Removable elbow braceDevice
Removable elbow brace
| Study group | Role | What they receive |
|---|---|---|
| Elbow cast | Active comparator | Device: Elbow cast Receives: Device: elbow cast |
| Removable elbow brace | Experimental | Device: Removable elbow brace Receives: Device: Removable elbow brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mayo score
Functional outcome as measured by the Mayo score at 4 weeks from the time of the initial injury
Measured: 1 month
Secondary outcomes (1)
pain
VAS score
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start2 Feb 2018 (estimated)
- Primary completion5 Feb 2019 (estimated)
- Study completion5 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radial FractureStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, pengzhang, Peking University People's Hospital
- Investigators
- peng zhang, MD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360318
- Sponsor's protocol ID
- CSG-03qtd
- Status last verified
- Nov 2017
- First submitted
- 28 Nov 2017
- Last updated
- 4 Dec 2017
- 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 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brace Versus Casting in Pediatric Radial Head Fractures
- ClinicalTrials.gov ID
- NCT03360318
- Acronym / sponsor ID
- CSG-03qtd
- Conditions
- Radial Fracture
- Keywords
- pediatric, elbow fractures, management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 2 Feb 2018 (estimated)
- Primary completion
- 5 Feb 2019 (estimated)
- Study completion
- 5 Feb 2019 (estimated)
- First posted
- 4 Dec 2017 (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.
Commare the pain and function of Brace Versus Casting in Pediatric Radial Head Fractures after 1 month
Detailed description
Radial Head Fractures are common injury in children. In this study, healthy children with Mason type I or II radial head fractures are planned to be included.
Outcome Measures: The primary outcome measure will be an assessment of functional daily activities as measured by the MAYO score at four weeks post injury. Secondary outcomes will include an assessment of pain scores using VAS.
Sample Size and Analysis: Assuming a standard deviation of 10%, alpha = 0.05, beta = 0.2 and 10% dropout rate yields a sample size of 150 patients. Secondary analyses will include Fisher's Exact test to compare proportions of children with full range of motion of the injured ankle at four weeks and with full baseline activity level at four months, and the area under the curve of a pain-time profile curve will be compared using a Student's t-test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elbow cast | Active comparator | Device: elbow castDevice: Elbow cast |
| Removable elbow brace | Experimental | Device: Removable elbow braceDevice: Removable elbow brace |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 5 to 18 years of age with one of the following fracture Undisplaced Maoson types I and II fractures of the radial head
Key exclusion criteria (4 listed)
- The diagnosis of elbow sprain or contusion; they occur primarily in adolescents with closed epiphyseal plates.
- All open fractures which require surgical debridement. All children at risk for pathological fractures such as those with congenital or acquired generalized bony disease.
- Congenital anomalies of the elbow. Patients with coagulopathies. Multisystem trauma and multiple fractures of the same or opposite limb. Patients cognitively and developmentally delayed with inability to express pain and/or difficult assessment of baseline activity level.
- Injuries greater than 72 hours old. Past history of surgery or closed reduction of the same elbow within the last 6 months or ankle trauma of the same ankle within 3 months.
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 |
|---|---|---|
| elbow castelbow cast | Device | Elbow cast |
| Removable elbow braceRemovable elbow brace | Device | Removable elbow brace |
Primary outcome
Mayo score
Time frame: 1 month
Functional outcome as measured by the Mayo score at 4 weeks from the time of the initial injury
1 secondary outcome
pain
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2017.
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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.
peng zhang, MD principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing elbow cast and Removable elbow brace in people with Radial Fracture, run by Peking University People's Hospital at 1 site in China.
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 4 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 4 Dec 2017. 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 China. 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 peng zhang, MD (13010029908, hcooh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mayo score (time frame: 1 month). 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 4 Dec 2017.