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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The standard follow-up protocol | No Intervention | follow-up and film every week at hospital | |
| The optimized follow-up protocol | Experimental | follow-up and film every week at hospital except the 3rd week is telemedicine follow-up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telemedicine follow-up in 3rd week | Other | Intervention group will be appointed with telemedicine follow-up in 3rd week after injury, instead of hospital follow-up visit. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Number of Participants with malunion, nonunion, joint stiffness and cast problem | From enrollment to the end of treatment at 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nonticha Thanthong, Doctor of medicine | Contact | (+66)898829505 | por-43@hotmail.co.th | |
| Chanika Angsanuntsukh, Diploma of orthopaedics | Contact | (+66)917767879 | achanika@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Ramathibodi Hospital, Mahidol University | Ratchathewi | Bangkok | 10400 | Thailand |
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| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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