The Optimized Follow-up Protocol for Pediatric Metaphyseal Forearm Fractures
1 other identifier
interventional
72
1 country
1
Brief Summary
The randomized controlled study which compare radiologic outcomes (loss of reduction rate) and complications in pediatric patients with displaced metaphyseal forearm fractures who underwent conservative treatment. The patients were assigned in two different follow-up protocols. In the control group, the patients will go to hospital for follow-up visit and film every week until 4th week after injury. In the intervention group, the patients will go to hospital for follow-up visit every week except in the 3rd week after injury they will be gotten telemedicine follow-up.
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 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2024
CompletedStudy Start
First participant enrolled
November 5, 2024
CompletedFirst Posted
Study publicly available on registry
November 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
November 12, 2024
November 1, 2024
2.2 years
November 5, 2024
November 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
loss of reduction rate
Angulation is more than 10 degree in coronal view or more than 20 degree in sagittal view
From enrollment to the end of treatment at 4 weeks
Secondary Outcomes (1)
Complications
From enrollment to the end of treatment at 4 weeks
Study Arms (2)
The standard follow-up protocol
NO INTERVENTIONfollow-up and film every week at hospital
The optimized follow-up protocol
EXPERIMENTALfollow-up and film every week at hospital except the 3rd week is telemedicine follow-up
Interventions
Intervention group will be appointed with telemedicine follow-up in 3rd week after injury, instead of hospital follow-up visit.
Eligibility Criteria
You may qualify if:
- Age 0-12 years
- Patients with distal metaphyseal forearm fractures in Ramathibodi hospital and Chakri Naruebodindra Medical Institute
- Presented to hospital within 72 hours of injury
You may not qualify if:
- Open fracture
- Operative treatment at 1st visit
- Neurovascular injury
- Polytraumatized patient
- Ipsilateral fracture of upper limb
- History of previous surgery in the affected arm
- Metabolic bone disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Ratchathewi, Bangkok, 10400, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sponsor Investigator
Study Record Dates
First Submitted
November 5, 2024
First Posted
November 7, 2024
Study Start
November 5, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
November 12, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share