Bone FracturesNCT01912365
Splinting Versus Casting for Type I Supracondylar Fractures
An observational study of Bone Fractures, run by University of British Columbia at 1 site in Canada.
Trial summary
Elbow fractures are very common in young children. Type I supracondylar fractures are stable fractures to the elbow that are treated conservatively across the world and typically heal very well without complications. There are several treatment options, including an above elbow cast or long arm splint. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Bone Fractures
- What is being tested?
- Above Elbow Cast and Long Arm Splint
- Type of treatment
- Surgery or procedure
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2013to Jun 2017
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Eligible participants will be recruited from the Emergency Department at BC Children's Hospital
Who may be able to join
- Ages 3-12
- Type 1 supracondylar fracture
Who cannot join
- A type 2 or 3 supracondylar fracture
- Neurovascular compromise associated with the fracture
- Previous diagnosis with a metabolic or structural bone disease
- Other fractures to ipsilateral upper extremity
- History of injury to affected elbow
Trial locations and contacts
1 site in 1 country.
Canada1 site
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
About this study
Official title: Splinting Versus Above Elbow Casting for Type I Supracondylar Fractures of the Humerus in Children: A Randomized Controlled Trial
Elbow fractures are very common in young children. Type I supracondylar fractures are stable fractures to the elbow that are treated conservatively across the world and typically heal very well without complications. There are several treatment options, including an above elbow cast or long arm splint. This study aims to determine if one treatment is no worse than the other in order to standardize the treatment of these fractures at our institution. The investigators hope to save families from extra hospital visits and reduce the amount of x-rays required for treatment of these fractures.
- Conditions
- Bone Fractures
- Being tested
- Above Elbow Cast, Long Arm Splint
- Keywords
- Fracture, Supracondylar, Pediatric, Orthopedic
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Above Elbow CastProcedure or surgery
Long Arm SplintProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Above Elbow Cast + Collar/cuff | Participants randomized to this group will be treated with an Above Elbow Cast \& collar/cuff for 3 weeks Receives: Procedure: Above Elbow Cast | |
| Long Arms Splint + Collar/Cuff | Participants randomized to this group will be treated with a long arm splint \& collar/cuff for 3 weeks Receives: Procedure: Long Arm Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baumann's Angle
Baumann's angle of the injured elbow will be measured 6 months following the injury
Measured: 6 Months
Secondary outcomes (2)
Humero-Capitellar Angle
Humero-Capitellar Angle will be measured 6 Months following the injury
Measured: 6 Months
Functional Outcome Questionnaire
All participants will complete the Activity Scale for Kids-P 6 months following the injury
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone FracturesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kishore Mulpuri, University of British Columbia
- Investigators
- Kishore Mulpuri, MBBS, MS, MHSc, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912365
- Sponsor's protocol ID
- H13-01520
- Status last verified
- Jan 2018
- First submitted
- 26 Jul 2013
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Siu C, Farrell S, Schaeffer EK, Doan Q, Dobbe A, Bone J, Reilly CW, Mulpuri K. Long-Arm Splinting Versus Above-Elbow Casting for Type 1 Supracondylar Fractures of the Humerus in Children: a Randomized Controlled Trial. SN Compr Clin Med. 2023;5(1):72. doi: 10.1007/s42399-023-01417-z. Epub 2023 Feb 3.
PubMed 36776416
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Splinting Versus Above Elbow Casting for Type I Supracondylar Fractures of the Humerus in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01912365
- Acronym / sponsor ID
- H13-01520
- Conditions
- Bone Fractures
- Keywords
- Fracture, Supracondylar, Pediatric, Orthopedic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 31 Jul 2013 (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.
Elbow fractures are very common in young children. Type I supracondylar fractures are stable fractures to the elbow that are treated conservatively across the world and typically heal very well without complications. There are several treatment options, including an above elbow cast or long arm splint. This study aims to determine if one treatment is no worse than the other in order to standardize the treatment of these fractures at our institution. The investigators hope to save families from extra hospital visits and reduce the amount of x-rays required for treatment of these fractures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Above Elbow Cast + Collar/cuff | – | Procedure: Above Elbow CastParticipants randomized to this group will be treated with an Above Elbow Cast \& collar/cuff for 3 weeks |
| Long Arms Splint + Collar/Cuff | – | Procedure: Long Arm SplintParticipants randomized to this group will be treated with a long arm splint \& collar/cuff for 3 weeks |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Eligible participants will be recruited from the Emergency Department at BC Children's Hospital
Key inclusion criteria (2 listed)
- Ages 3-12
- Type 1 supracondylar fracture
Key exclusion criteria (5 listed)
- A type 2 or 3 supracondylar fracture
- Neurovascular compromise associated with the fracture
- Previous diagnosis with a metabolic or structural bone disease
- Other fractures to ipsilateral upper extremity
- History of injury to affected elbow
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 |
|---|---|---|
| Above Elbow Cast | Procedure or surgery | Above Elbow Cast + Collar/cuff |
| Long Arm Splint | Procedure or surgery | Long Arms Splint + Collar/Cuff |
Primary outcome
Baumann's Angle
Time frame: 6 Months
Baumann's angle of the injured elbow will be measured 6 months following the injury
2 secondary outcomes
Humero-Capitellar Angle
Time frame: 6 Months
Functional Outcome Questionnaire
Time frame: 6 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 10 Jan 2018.
- Derived from this study: PubMed 36776416Siu C, Farrell S, Schaeffer EK, Doan Q, Dobbe A, Bone J, Reilly CW, Mulpuri K. Long-Arm Splinting Versus Above-Elbow Casting for Type 1 Supracondylar Fractures of the Humerus in Children: a Randomized Controlled Trial. SN Compr Clin Med. 2023;5(1):72. doi: 10.1007/s42399-023-01417-z. Epub 2023 Feb 3.
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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.
Kishore Mulpuri, MBBS, MS, MHSc principal investigator
University of British Columbia
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 Bone Fractures, run by University of British Columbia at 1 site in Canada.
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 2 inclusion and 5 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 10 Jan 2018. 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 Canada. 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?
Baumann's Angle (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01912365, which also lists 1 linked publication.
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 10 Jan 2018.