Supracondylar Humerus FractureNCT06496672
The Wrist-Free Study - Comparing Traditional Above Elbow Casts to Ones That Free the Wrist
A study testing Modified long arm cast and Traditional long arm cast in people with Supracondylar Humerus Fracture, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
This randomized controlled trial compares clinical outcomes, patient comfort and satisfaction of freeing the wrist in casts for supracondylar humerus fractures in children. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Supracondylar Humerus Fracture
- What is being tested?
- Modified long arm cast and Traditional long arm cast
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSingapore
- Study dates
- 9 Nov 2023to 31 Aug 2024
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Type I and Type IIa Supracondylar Humerus Fracture
Who cannot join
- History of elbow injury
- Polytrauma
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
KK Women's and Children's Hospital
Singapore, 229899
Kenneth PL Wong, FRCS, +6592355960, kenneth.wong.p.l@singhealth.com.sg
About this study
Official title: The Wrist-Free Study- A Randomized Controlled Trial Comparing Traditional Above Elbow Casts to Ones That Free the Wrist in Pediatric Supracondylar Humerus Fractures
This randomized controlled trial compares clinical outcomes, patient comfort and satisfaction of freeing the wrist in casts for supracondylar humerus fractures in children.
- Conditions
- Supracondylar Humerus Fracture
- Being tested
- Modified long arm cast, Traditional long arm cast
- Keywords
- Pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified long arm castProcedure or surgery
A shorter cast that frees the wrist
Traditional long arm castProcedure or surgery
Current standard of care where the cast extends up to the palmar bar
| Study group | Role | What they receive |
|---|---|---|
| Traditional | Active comparator | Participants in this group receive the existing treatment, which is a cast that terminates at the palmar bar. Receives: Procedure: Traditional long arm cast |
| Modified | Experimental | Participants in this group receive the experimental treatment, a cast that terminates at the wrist. Receives: Procedure: Modified long arm cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Measured using QDASH
Measured: 3-4 Weeks
Secondary outcomes (1)
Complications in healing
Observe for loss of reduction in fracture
Measured: 3-4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start9 Nov 2023
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Supracondylar Humerus 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
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Kenneth PL Wong, FRCS, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496672
- Sponsor's protocol ID
- KKWCHWristFree
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khoshbin A, Leroux T, Wasserstein D, Wolfstadt J, Law PW, Mahomed N, Wright JG. The epidemiology of paediatric supracondylar fracture fixation: a population-based study. Injury. 2014 Apr;45(4):701-8. doi: 10.1016/j.injury.2013.10.004. Epub 2013 Oct 17.
PubMed 24183392Micheloni GM, Novi M, Leigheb M, Giorgini A, Porcellini G, Tarallo L. Supracondylar fractures in children: management and treatment. Acta Biomed. 2021 Jul 26;92(S3):e2021015. doi: 10.23750/abm.v92iS3.11725.
PubMed 34313666Boyd AS, Benjamin HJ, Asplund C. Splints and casts: indications and methods. Am Fam Physician. 2009 Sep 1;80(5):491-9.
PubMed 19725490Shenoy PM, Islam A, Puri R. Current Management of Paediatric Supracondylar Fractures of the Humerus. Cureus. 2020 May 15;12(5):e8137. doi: 10.7759/cureus.8137.
PubMed 32550057Vaquero-Picado A, Gonzalez-Moran G, Moraleda L. Management of supracondylar fractures of the humerus in children. EFORT Open Rev. 2018 Oct 1;3(10):526-540. doi: 10.1302/2058-5241.3.170049. eCollection 2018 Oct.
PubMed 30662761
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Wrist-Free Study- A Randomized Controlled Trial Comparing Traditional Above Elbow Casts to Ones That Free the Wrist in Pediatric Supracondylar Humerus Fractures
- ClinicalTrials.gov ID
- NCT06496672
- Acronym / sponsor ID
- KKWCHWristFree
- Conditions
- Supracondylar Humerus Fracture
- Keywords
- Pediatric
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 11 Jul 2024 (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.
This randomized controlled trial compares clinical outcomes, patient comfort and satisfaction of freeing the wrist in casts for supracondylar humerus fractures in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional | Active comparator | Procedure: Traditional long arm castParticipants in this group receive the existing treatment, which is a cast that terminates at the palmar bar. |
| Modified | Experimental | Procedure: Modified long arm castParticipants in this group receive the experimental treatment, a cast that terminates at the wrist. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Type I and Type IIa Supracondylar Humerus Fracture
Key exclusion criteria (2 listed)
- History of elbow injury
- Polytrauma
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 |
|---|---|---|
| Modified long arm castA shorter cast that frees the wrist | Procedure or surgery | Modified |
| Traditional long arm castCurrent standard of care where the cast extends up to the palmar bar | Procedure or surgery | Traditional |
Primary outcome
Patient Satisfaction
Time frame: 3-4 Weeks
Measured using QDASH
1 secondary outcome
Complications in healing
Time frame: 3-4 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Background: PubMed 24183392Khoshbin A, Leroux T, Wasserstein D, Wolfstadt J, Law PW, Mahomed N, Wright JG. The epidemiology of paediatric supracondylar fracture fixation: a population-based study. Injury. 2014 Apr;45(4):701-8. doi: 10.1016/j.injury.2013.10.004. Epub 2013 Oct 17.
- Background: PubMed 34313666Micheloni GM, Novi M, Leigheb M, Giorgini A, Porcellini G, Tarallo L. Supracondylar fractures in children: management and treatment. Acta Biomed. 2021 Jul 26;92(S3):e2021015. doi: 10.23750/abm.v92iS3.11725.
- Background: PubMed 19725490Boyd AS, Benjamin HJ, Asplund C. Splints and casts: indications and methods. Am Fam Physician. 2009 Sep 1;80(5):491-9.
- Background: PubMed 32550057Shenoy PM, Islam A, Puri R. Current Management of Paediatric Supracondylar Fractures of the Humerus. Cureus. 2020 May 15;12(5):e8137. doi: 10.7759/cureus.8137.
- Background: PubMed 30662761Vaquero-Picado A, Gonzalez-Moran G, Moraleda L. Management of supracondylar fractures of the humerus in children. EFORT Open Rev. 2018 Oct 1;3(10):526-540. doi: 10.1302/2058-5241.3.170049. eCollection 2018 Oct.
- Individual participant dataSharing planned: No
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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.
Kenneth PL Wong, FRCS principal investigator
KK Women's and Children'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 Modified long arm cast and Traditional long arm cast in people with Supracondylar Humerus 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 2 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 11 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kenneth PL Wong, FRCS (+6592355960, kenneth.wong.p.l@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction (time frame: 3-4 Weeks). 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 NCT06496672, which also lists 5 linked publications.
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 11 Jul 2024.