Набор скоро начнётся NCT06678568

The Optimized Follow-up Protocol for Pediatric Metaphyseal Forearm Fractures

Без фазы С лечением Wrist Fracture

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: telemedicine follow-up in 3rd week.
Кому может быть актуально: Состояния в реестре: Wrist Fracture. Базовые параметры: до 12 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Таиланд
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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:

1. 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. 2. 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.

Вмешательства

Другое telemedicine follow-up in 3rd week
Intervention group will be appointed with telemedicine follow-up in 3rd week after injury, instead of hospital follow-up visit.

Первичные конечные точки

loss of reduction rate [Срок оценки: From enrollment to the end of treatment at 4 weeks]

Вторичные конечные точки (1)

Complications [Срок оценки: From enrollment to the end of treatment at 4 weeks]

Критерии участия

Критерии включения

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