Type I Supracondylar Fracture of the HumerusNCT00904137
Treatment of Type I Supracondylar Fractures of the Humerus
A study testing Cast, Splint and Tape in people with Type I Supracondylar Fracture of the Humerus, run by University of British Columbia at 1 site in Canada.
Trial summary
Type I supracondylar fractures are elbow fractures that occur in children aged 3-10 years. Many different treatment options exist to treat this type of fracture. The purpose of this study is to compare three different treatment modalities with regards to pain experienced during treatment, the amount of pain medication… Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Type I Supracondylar Fracture of the Humerus
- What is being tested?
- Cast, Splint and Tape
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- May 2009to Jan 2014
- 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 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- patients aged 4-12 years who present to the Emergency department at BC Children's hospital with a history of elbow trauma, and are diagnosed by the staff emergency physician to have a Type I supracondylar fracture of the humerus (as seen on AP and lateral radiographs of the elbow)
Who cannot join
- patients with neurovascular compromise associated with the fracture
- a pre-existing diagnosis of metabolic or structural bone disease that predisposes them to fractures
- presence of other fractures of the ipsilateral upper extremity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Taping Versus Splinting Versus Above Elbow Casting for Type I Supracondylar Fractures of the Humerus in Children: A Randomized Controlled Trial
Type I supracondylar fractures are elbow fractures that occur in children aged 3-10 years. Many different treatment options exist to treat this type of fracture. The purpose of this study is to compare three different treatment modalities with regards to pain experienced during treatment, the amount of pain medication needed during treatment, and any short-term complications. We hypothesize that above elbow casting and long-arm splinting will result in less pain and have fewer complications than taping the elbow in flexion.
Read the detailed description
Patients who meet the inclusion criteria will be enrolled into the study either by the attending physician in the Emergency Department at BC Children's hospital or by one of the study investigators. They will be randomly assigned to one of three treatment groups: above elbow cast, long arm splint, or tape. After being treated, patients will be required to fill in a daily pain diary describing their level of pain and how much analgesia they are requiring. They will also be followed by regular phone calls to track any complications of treatment (e.g. loosening or shifting of cast/ splint/ tape, any skin breakdown, etc.). Patients will be seen for follow-up at three weeks post-injury in the Orthopedics Clinic at BCCH to have radiographs repeated, finish their treatment, and hand in their pain diaries.
- Being tested
- Cast, Splint, Tape
- Keywords
- Supracondylar fracture, humerus, elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CastProcedure or surgery
SplintProcedure or surgery
TapeProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Cast | Active comparator | Above elbow fiberglass cast with a collar-and-cuff Receives: Procedure: Cast |
| Splint | Active comparator | Long arm posterior plaster splint with a collar-and-cuff Receives: Procedure: Splint |
| Tape | Active comparator | Elastoplast tape applied to keep the elbow in flexion, with a collar-and-cuff Receives: Procedure: Tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean pain intensity and median pain duration over treatment period
Measured: 3 weeks
Secondary outcomes (1)
Amount of analgesia required during treatment period, incidence of complications associated with treatment
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2009 (estimated)
- Study startMay 2009
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: We were unable to recruit the appropriate numbers as parents did not want to randomize their child for the treatments options.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type I Supracondylar Fracture of the HumerusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 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, Principal investigator, University of British ColumbiaRenjit Varghese, Study director, University of British ColumbiaLisa Dyke, Study director, University of British ColumbiaFiroz Miyanji, Study director, University of British ColumbiaChristopher Reilly, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904137
- Sponsor's protocol ID
- H08-02904
- Status last verified
- Jan 2018
- First submitted
- 15 May 2009
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
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
- Taping Versus Splinting Versus Above Elbow Casting for Type I Supracondylar Fractures of the Humerus in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00904137
- Acronym / sponsor ID
- H08-02904
- Keywords
- Supracondylar fracture, humerus, elbow
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We were unable to recruit the appropriate numbers as parents did not want to randomize their child for the treatments options.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 19 May 2009 (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.
Type I supracondylar fractures are elbow fractures that occur in children aged 3-10 years. Many different treatment options exist to treat this type of fracture. The purpose of this study is to compare three different treatment modalities with regards to pain experienced during treatment, the amount of pain medication needed during treatment, and any short-term complications. We hypothesize that above elbow casting and long-arm splinting will result in less pain and have fewer complications than taping the elbow in flexion.
Detailed description
Patients who meet the inclusion criteria will be enrolled into the study either by the attending physician in the Emergency Department at BC Children's hospital or by one of the study investigators. They will be randomly assigned to one of three treatment groups: above elbow cast, long arm splint, or tape. After being treated, patients will be required to fill in a daily pain diary describing their level of pain and how much analgesia they are requiring. They will also be followed by regular phone calls to track any complications of treatment (e.g. loosening or shifting of cast/ splint/ tape, any skin breakdown, etc.). Patients will be seen for follow-up at three weeks post-injury in the Orthopedics Clinic at BCCH to have radiographs repeated, finish their treatment, and hand in their pain diaries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cast | Active comparator | Procedure: CastAbove elbow fiberglass cast with a collar-and-cuff |
| Splint | Active comparator | Procedure: SplintLong arm posterior plaster splint with a collar-and-cuff |
| Tape | Active comparator | Procedure: TapeElastoplast tape applied to keep the elbow in flexion, with a collar-and-cuff |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- patients aged 4-12 years who present to the Emergency department at BC Children's hospital with a history of elbow trauma, and are diagnosed by the staff emergency physician to have a Type I supracondylar fracture of the humerus (as seen on AP and lateral radiographs of the elbow)
Key exclusion criteria (3 listed)
- patients with neurovascular compromise associated with the fracture
- a pre-existing diagnosis of metabolic or structural bone disease that predisposes them to fractures
- presence of other fractures of the ipsilateral upper extremity
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 |
|---|---|---|
| Cast | Procedure or surgery | Cast |
| Splint | Procedure or surgery | Splint |
| Tape | Procedure or surgery | Tape |
Primary outcome
Mean pain intensity and median pain duration over treatment period
Time frame: 3 weeks
1 secondary outcome
Amount of analgesia required during treatment period, incidence of complications associated with treatment
Time frame: 3 weeks
Results and safety
The study was stopped early (reason given: We were unable to recruit the appropriate numbers as parents did not want to randomize their child for the treatments options.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
Related trials for Type I Supracondylar Fracture of the Humerus
Recruiting
Management of Type 1 Supracondylar Humeral Fractures
Elbow Fracture, Trauma
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 principal investigator
University of British Columbia
Renjit Varghese study director
University of British Columbia
Lisa Dyke study director
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?
A study testing Cast, Splint and Tape in people with Type I Supracondylar Fracture of the Humerus, 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 1 inclusion and 3 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: stopped early, 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 was stopped early (reason given: We were unable to recruit the appropriate numbers as parents did not want to randomize their child for the treatments options.). Results are not available in the source record.
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?
Mean pain intensity and median pain duration over treatment period (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 10 Jan 2018.