The Wrist-Free Study - Comparing Traditional Above Elbow Casts to Ones That Free the Wrist
The Wrist-Free Study- A Randomized Controlled Trial Comparing Traditional Above Elbow Casts to Ones That Free the Wrist in Pediatric Supracondylar Humerus Fractures
1 other identifier
interventional
76
1 country
1
Brief Summary
This randomized controlled trial compares clinical outcomes, patient comfort and satisfaction of freeing the wrist in casts for supracondylar humerus fractures in children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 9, 2023
CompletedFirst Submitted
Initial submission to the registry
July 4, 2024
CompletedFirst Posted
Study publicly available on registry
July 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedJuly 11, 2024
July 1, 2024
10 months
July 4, 2024
July 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient Satisfaction
Measured using QDASH
3-4 Weeks
Secondary Outcomes (1)
Complications in healing
3-4 Weeks
Study Arms (2)
Traditional
ACTIVE COMPARATORParticipants in this group receive the existing treatment, which is a cast that terminates at the palmar bar.
Modified
EXPERIMENTALParticipants in this group receive the experimental treatment, a cast that terminates at the wrist.
Interventions
Current standard of care where the cast extends up to the palmar bar
Eligibility Criteria
You may qualify if:
- Type I and Type IIa Supracondylar Humerus Fracture
You may not qualify if:
- History of elbow injury
- Polytrauma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
KK Women's and Children's Hospital
Singapore, 229899, Singapore
Related Publications (5)
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.
PMID: 24183392BACKGROUNDMicheloni 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.
PMID: 34313666BACKGROUNDBoyd AS, Benjamin HJ, Asplund C. Splints and casts: indications and methods. Am Fam Physician. 2009 Sep 1;80(5):491-9.
PMID: 19725490BACKGROUNDShenoy 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.
PMID: 32550057BACKGROUNDVaquero-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.
PMID: 30662761BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth PL Wong, FRCS
KK Women's and Children's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2024
First Posted
July 11, 2024
Study Start
November 9, 2023
Primary Completion
August 31, 2024
Study Completion
August 31, 2024
Last Updated
July 11, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share