Wrist FractureNCT06678568
The Optimized Follow-up Protocol for Pediatric Metaphyseal Forearm Fractures
A study testing telemedicine follow-up in 3rd week in people with Wrist Fracture, run by Nonticha Thanthong at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrist Fracture
- What is being tested?
- telemedicine follow-up in 3rd week
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteThailand
- Study dates
- 5 Nov 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Ratchathewi, Bangkok, 10400
About this study
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.
Read the 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.
- Conditions
- Wrist Fracture
- Being tested
- telemedicine follow-up in 3rd week
- Keywords
- metaphyseal forearm fracture, loss of reduction, follow-up protocol, wrist fracture
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telemedicine follow-up in 3rd weekOther
Intervention group will be appointed with telemedicine follow-up in 3rd week after injury, instead of hospital follow-up visit.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: telemedicine follow-up in 3rd week |
What is being measured
The primary outcome is the main question the study is designed to answer.
loss of reduction rate
Angulation is more than 10 degree in coronal view or more than 20 degree in sagittal view
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (1)
Complications
Number of Participants with malunion, nonunion, joint stiffness and cast problem
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start5 Nov 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrist FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nonticha Thanthong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nonticha Thanthong, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678568
- Sponsor's protocol ID
- MURA2024/689
- Status last verified
- Nov 2024
- First submitted
- 5 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimized Follow-up Protocol for Pediatric Metaphyseal Forearm Fractures
- ClinicalTrials.gov ID
- NCT06678568
- Acronym / sponsor ID
- MURA2024/689
- Conditions
- Wrist Fracture
- Keywords
- metaphyseal forearm fracture, loss of reduction, follow-up protocol, wrist fracture
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Nonticha ThanthongUniversity, hospital or other
- Study start
- 5 Nov 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The standard follow-up protocol | No intervention | –follow-up and film every week at hospital |
| The optimized follow-up protocol | Experimental | Other: telemedicine follow-up in 3rd weekfollow-up and film every week at hospital except the 3rd week is telemedicine follow-up |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Open fracture
- Operative treatment at 1st visit
- Neurovascular injury
- Polytraumatized patient
- Ipsilateral fracture of upper limb
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telemedicine follow-up in 3rd weekIntervention group will be appointed with telemedicine follow-up in 3rd week after injury, instead of hospital follow-up visit. | Other | The optimized follow-up protocol |
Primary outcome
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
1 secondary outcome
Complications
Time frame: From enrollment to the end of treatment at 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telemedicine follow-up in 3rd week in people with Wrist Fracture, run by Nonticha Thanthong at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nonticha Thanthong, Doctor of medicine ((+66)898829505, por-43@hotmail.co.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
loss of reduction rate (time frame: From enrollment to the end of treatment at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.