Pediatric Supracondylar Humeral FractureNCT05430074
HM vs Fibreglass Cast Immbolization for Supracondylar Fractures
A study testing HM Cast and Fibreglass Cast in people with Pediatric Supracondylar Humeral Fracture, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
Supracondylar humeral fractures are the most common elbow fractures in children and cast immobilization continues to remain as the recommended treatment for modified Gartland's classification Type I and Type IIa injuries. Read more about this study
- Who is it for?
- Ages 0 to 10 years
- Conditions the study is for
- Pediatric Supracondylar Humeral Fracture
- What is being tested?
- HM Cast and Fibreglass Cast
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteSingapore
- Study dates
- 16 Aug 2022to 28 Nov 2022
- 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 0 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- First Presentation of Supracondylar humeral fracture (Type I and IIa modified Gartland's classification)
Who cannot join
- Prior treatment of supracondylar humeral fracture
- Previous elbow injuries
- Open fractures
- Polytrauma
- Neurovascular injuries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Paediatric Supracondylar Humeral Fracture With Cast Immobilization: A Randomized Controlled Trial - Hybrid Mesh Versus Fibreglass
Supracondylar humeral fractures are the most common elbow fractures in children and cast immobilization continues to remain as the recommended treatment for modified Gartland's classification Type I and Type IIa injuries. Apart from plaster of Paris and fibreglass casts, the use of waterproof, tubular hybrid mesh (HM) casts have been gaining traction for cast immobilization. Although the use of HM cast has been reported to have similar clinical outcomes and overall patient satisfaction scores to the fibreglass cast, the results of the recent studies are only limited and generalizable only to paediatric distal radius fractures.
As the application method of HM and fibreglass casts are fundamentally different, it has not been reported if the difference in application duration between the cast materials is significant and its potential implications in outpatient clinic operation.
Read more
Hence, through a randomized controlled trial, this study primarily aims to investigate if the clinical outcomes, patient satisfaction and duration of cast application with the HM casts would be comparable with fibreglass casts in children with supracondylar humeral fractures.
Through this study, the investigators hope to evaluate the advantages and disadvantages of the respective casting material which may better aid physicians in deciding a more appropriate cast material for treating paediatric supracondylar humeral fractures with cast immobilization and the implications of casting duration on clinic operations.
- Conditions
- Pediatric Supracondylar Humeral Fracture
- Being tested
- HM Cast, Fibreglass Cast
- Keywords
- Supracondylar humeral fracture, Pediatric fracture, Hybrid mesh cast, Fibreglass cast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM CastDevice
Subjects assigned to this arm will be treated via cast immobilisation with the use of HM casts.
Fibreglass CastDevice
Subjects assigned to this arm will be treated via cast immobilisation with the use of Fibreglass casts.
| Study group | Role | What they receive |
|---|---|---|
| HM Cast | Other | Not described Receives: Device: HM Cast |
| Fibreglass Cast | Other | Not described Receives: Device: Fibreglass Cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcome - Loss of Reduction
Based on the radiographs taken 4 weeks after casting, the Baumann's angle will used to assess for any loss of reduction.
Measured: 4 weeks post-casting
Comfort and Overall Satisfaction
Through a questionnaire, the patients and their parents will be asked to rate the patients' experience on adaptability, weight of the cast, itch, heat, sweatiness, smell, comfort and overall satisfaction. For each question, on the scales of 1 to 5, the rating of 1 would designate as the least desirable option and the rating of 5 being the most desirable option.
Measured: 4 weeks post-casting
Presence of Skin Rash
The presence of skin rash will be assessed by the study team member upon cast removal.
Measured: 4 weeks post-casting
Secondary outcomes (1)
Duration of Cast Application
The duration of each cast application with the respective cast materials will be recorded and analysed.
Measured: During Procedure (Cast Application - First Visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start16 Aug 2022
- Primary completion28 Nov 2022
- Study completion28 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Supracondylar Humeral FractureStudies of the same condition, open and under way.
- More trials run by KK Women's and Children'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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kenneth Wong Pak Leung, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430074
- Sponsor's protocol ID
- CIRB Ref: 2022/2409
- Status last verified
- Oct 2024
- First submitted
- 16 Jun 2022
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Paediatric Supracondylar Humeral Fracture With Cast Immobilization: A Randomized Controlled Trial - Hybrid Mesh Versus Fibreglass
- ClinicalTrials.gov ID
- NCT05430074
- Acronym / sponsor ID
- CIRB Ref: 2022/2409
- Conditions
- Pediatric Supracondylar Humeral Fracture
- Keywords
- Supracondylar humeral fracture, Pediatric fracture, Hybrid mesh cast, Fibreglass cast
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 28 Nov 2022 (actual)
- Study completion
- 28 Nov 2022 (actual)
- First posted
- 24 Jun 2022 (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.
Supracondylar humeral fractures are the most common elbow fractures in children and cast immobilization continues to remain as the recommended treatment for modified Gartland's classification Type I and Type IIa injuries. Apart from plaster of Paris and fibreglass casts, the use of waterproof, tubular hybrid mesh (HM) casts have been gaining traction for cast immobilization. Although the use of HM cast has been reported to have similar clinical outcomes and overall patient satisfaction scores to the fibreglass cast, the results of the recent studies are only limited and generalizable only to paediatric distal radius fractures.
As the application method of HM and fibreglass casts are fundamentally different, it has not been reported if the difference in application duration between the cast materials is significant and its potential implications in outpatient clinic operation.
Hence, through a randomized controlled trial, this study primarily aims to investigate if the clinical outcomes, patient satisfaction and duration of cast application with the HM casts would be comparable with fibreglass casts in children with supracondylar humeral fractures.
Through this study, the investigators hope to evaluate the advantages and disadvantages of the respective casting material which may better aid physicians in deciding a more appropriate cast material for treating paediatric supracondylar humeral fractures with cast immobilization and the implications of casting duration on clinic operations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HM Cast | Other | Device: HM Cast |
| Fibreglass Cast | Other | Device: Fibreglass Cast |
Who may qualify
- Ages
- 0 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- First Presentation of Supracondylar humeral fracture (Type I and IIa modified Gartland's classification)
Key exclusion criteria (5 listed)
- Prior treatment of supracondylar humeral fracture
- Previous elbow injuries
- Open fractures
- Polytrauma
- Neurovascular injuries
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 |
|---|---|---|
| HM CastSubjects assigned to this arm will be treated via cast immobilisation with the use of HM casts. | Device | HM Cast |
| Fibreglass CastSubjects assigned to this arm will be treated via cast immobilisation with the use of Fibreglass casts. | Device | Fibreglass Cast |
Primary outcome
Clinical Outcome - Loss of Reduction
Time frame: 4 weeks post-casting
Based on the radiographs taken 4 weeks after casting, the Baumann's angle will used to assess for any loss of reduction.
Comfort and Overall Satisfaction
Time frame: 4 weeks post-casting
Through a questionnaire, the patients and their parents will be asked to rate the patients' experience on adaptability, weight of the cast, itch, heat, sweatiness, smell, comfort and overall satisfaction. For each question, on the scales of 1 to 5, the rating of 1 would designate as the least desirable option and the rating of 5 being the most desirable option.
Presence of Skin Rash
Time frame: 4 weeks post-casting
The presence of skin rash will be assessed by the study team member upon cast removal.
1 secondary outcome
Duration of Cast Application
Time frame: During Procedure (Cast Application - First Visit)
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 17 Oct 2024.
- Individual participant dataSharing planned: No
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Supracondylar Post-Operative Pain Study
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HM Cast and Fibreglass Cast in people with Pediatric Supracondylar Humeral Fracture, run by KK Women's and Children's Hospital at 1 site in Singapore.
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 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 17 Oct 2024. 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 Singapore. 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?
Clinical Outcome - Loss of Reduction (time frame: 4 weeks post-casting). The study lists 3 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 17 Oct 2024.