The Optimized Follow-up Protocol for Pediatric Metaphyseal Forearm Fractures
Study Overview
Status
Intervention / Treatment
Detailed Description
Randomization of patients for 2 different follow-up protocols
Objective: to compare loss of reduction rate by angulation measurement and prevalence of complications in patients with displaced metaphyseal forearm fractures who underwent conservative treatment.
Method:
Patients will be randomly assigned to one of two groups using various block computerized randomization. Randomization will be performed using STATA version 16.0, Statacorp, College Station, Texas, USA
Interventions:
Group 1 (control group): The patients will go to hospital for follow-up visit and film every week until 4th week after injury.
Group 2 (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.
Treatment Allocation and concealment:
A randomization will prepare with sealed envelopes containing assigned follow-up protocols for each patient.
The envelopes will be labeled with the study ID.
Blinding:
Because of the two different of follow-up protocol, we cannot blind the protocol from participants, physicians and assessors.
Outcomes:
- Primary outcome is loss of reduction rate using angulation measurement. The definition of loss of reduction angulation is angulation which is more than 10 degree in coronal view or more than 20 degree in sagittal view. Angulation measurement will be measured in bisector between longitudinal axis and center of diaphysis. Angulation will be measured by two physicians and two times using PACS (Picture Archiving and Communication System) in Ramathibodi hospital.
- Secondary outcomes are other complications such as malunion, nonunion, joint stiffness and cast problem
Statistical Analysis Plan:
Data will be recorded in Microsoft Excel and imported to STATA version 16.0 for re-check.
For continuous data, use mean and standard deviation (S.D.) For categorical data, use frequency and percentage For comparing non-normal distribution between group, use Mann-Whitney test and for continuous data, use Fisher's exact test Define the Statistical significant is p-value < 0.05 Data analysis will be performed with STATA version 16.0, Statacorp, College Station, Texas, USA.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nonticha Thanthong, Doctor of medicine
- Phone Number: (+66)898829505
- Email: por-43@hotmail.co.th
Study Contact Backup
- Name: Chanika Angsanuntsukh, Diploma of orthopaedics
- Phone Number: (+66)917767879
- Email: achanika@gmail.com
Study Locations
-
-
Bangkok
-
Ratchathewi, Bangkok, Thailand, 10400
- Faculty of Medicine Ramathibodi Hospital, Mahidol University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: The standard follow-up protocol
follow-up and film every week at hospital
|
|
|
Experimental: The optimized follow-up protocol
follow-up and film every week at hospital except the 3rd week is telemedicine follow-up
|
Intervention group will be appointed with telemedicine follow-up in 3rd week after injury, instead of hospital follow-up visit.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
loss of reduction rate
Time Frame: From enrollment to the end of treatment at 4 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Complications
Time Frame: From enrollment to the end of treatment at 4 weeks
|
Such as malunion, nonunion, joint stiffness and cast problem
|
From enrollment to the end of treatment at 4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MURA2024/689
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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