Fracture of RadiusNCT05244317
Removable Splint Versus Cast in the Treatment of Distal Radius Fracture in Children
A study testing cast and splint in people with Fracture of Radius, run by University of Duhok at 1 site in Iraq.
Trial summary
Refugees live in camps under unusual living conditions. The children in the camps may not have enough safe facilities to play. If an injury occurred in these children, the classical and adequate regime of treatment may not be available. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Fracture of Radius
- What is being tested?
- cast and splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteIraq
- Study dates
- 20 Sep 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: between 2-12 years old age.
- Sex: both male and female.
- Address: living in one of the refugees' camps in the Duhok Government.
- Duration of symptoms: less than 7 days.
- Type of injury: fracture at the distal end of radius proofed by a radiograph film in two views (posteroanterior and lateral).
- Type of fracture: it may be any of the followings:
Show all 9Show fewer
- torus (buckle) fracture,
- undisplaced or minimally displaced fracture distal radius physis (type 1 and 2 only) that do not need reduction.
- undisplaced or minimal displaced metaphyseal fracture that does not need reduction. Note: The minimally displaced fracture will be considered when the fracture fragments have a tilt of fewer than 15 degrees and shift less than 5 millimeters at the fracture site in both views.
Who cannot join
- open fractures
- pathological fractures
- displaced fractures that need reduction
- delayed presentation beyond 7 days
- associated fracture of the ulnar bone
- polytraumatic cases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Removable Splint Versus Cast in the Treatment of Distal Radius Fracture in Children of Refugees' Camps: a Randomized Controlled Trial
Refugees live in camps under unusual living conditions. The children in the camps may not have enough safe facilities to play. If an injury occurred in these children, the classical and adequate regime of treatment may not be available. Hence, it may be valuable to find simple, cheap, and safe methods of treatment for their injuries.
Read the detailed description
Fractures of the distal forearm (especially radius) are the most common fracture reported in childhood and a frequent reason for visiting the emergency unit and orthopedic clinic in hospitals. Because of the age of patients and proximity to the joint, these fractures heal well and have a good ability to remodel the bone even with mild displacement. Therefore, most of these fractures are treated conservatively by a short arm cast with frequent visits to the orthopedic clinic within 4-6 weeks without significant complications. Several studies report successful treatment of these fractures by removable splint as a substitute for the cast. The splints proved to be safe and cost-effective in managing these common minor injuries in children under usual living conditions.
Refugees live in camps under unusual living conditions. The children in these camps may not have enough safe facilities to play. If they got an injury, the classical and adequate regime of treatment may not be available. Hence, it may be valuable to find simple, cheap, and safe methods of treatment for their injuries.
- Conditions
- Fracture of Radius
- Being tested
- cast, splint
- Keywords
- splint, cast
- Medical subject headings
- Radius Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
castDevice
the cast of the upper limb from just below elbow joint to the knuckle of fingers
splintDevice
Removable splint
| Study group | Role | What they receive |
|---|---|---|
| cast group | Placebo comparator | treatment of the participant of this group will be by the standard method which is by casting Receives: Device: cast |
| splint group | Experimental | treatment of the participant of this group will be by the removable splint Receives: Device: splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
complication
proportion of complication occurrence
Measured: up to 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start20 Sep 2021
- Primary completion30 May 2023
- Study completion30 Jun 2023
Why it stopped: no cases included
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture of RadiusStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Duhok
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jagar Omar Doski, University of Duhok
- Investigators
- Jagar O Doski, Study chair, University of Duhok
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244317
- Sponsor's protocol ID
- UDuhok
- Status last verified
- Dec 2024
- First submitted
- 15 Jan 2022
- Last updated
- 30 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: personal contact with the investigator
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Removable Splint Versus Cast in the Treatment of Distal Radius Fracture in Children of Refugees' Camps: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05244317
- Acronym / sponsor ID
- UDuhok
- Conditions
- Fracture of Radius
- Keywords
- splint, cast
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no cases included
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of DuhokUniversity, hospital or other
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 17 Feb 2022 (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.
Refugees live in camps under unusual living conditions. The children in the camps may not have enough safe facilities to play. If an injury occurred in these children, the classical and adequate regime of treatment may not be available. Hence, it may be valuable to find simple, cheap, and safe methods of treatment for their injuries.
Detailed description
Fractures of the distal forearm (especially radius) are the most common fracture reported in childhood and a frequent reason for visiting the emergency unit and orthopedic clinic in hospitals. Because of the age of patients and proximity to the joint, these fractures heal well and have a good ability to remodel the bone even with mild displacement. Therefore, most of these fractures are treated conservatively by a short arm cast with frequent visits to the orthopedic clinic within 4-6 weeks without significant complications. Several studies report successful treatment of these fractures by removable splint as a substitute for the cast. The splints proved to be safe and cost-effective in managing these common minor injuries in children under usual living conditions.
Refugees live in camps under unusual living conditions. The children in these camps may not have enough safe facilities to play. If they got an injury, the classical and adequate regime of treatment may not be available. Hence, it may be valuable to find simple, cheap, and safe methods of treatment for their injuries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cast group | Placebo comparator | Device: casttreatment of the participant of this group will be by the standard method which is by casting |
| splint group | Experimental | Device: splinttreatment of the participant of this group will be by the removable splint |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Age: between 2-12 years old age.
- Sex: both male and female.
- Address: living in one of the refugees' camps in the Duhok Government.
- Duration of symptoms: less than 7 days.
- Type of injury: fracture at the distal end of radius proofed by a radiograph film in two views (posteroanterior and lateral).
Key exclusion criteria (6 listed)
- open fractures
- pathological fractures
- displaced fractures that need reduction
- delayed presentation beyond 7 days
- associated fracture of the ulnar bone
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 |
|---|---|---|
| castthe cast of the upper limb from just below elbow joint to the knuckle of fingers | Device | cast group |
| splintRemovable splint | Device | splint group |
Primary outcome
complication
Time frame: up to 12 weeks.
proportion of complication occurrence
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Individual participant dataSharing planned: Undecided. personal contact with the investigator
Related trials for Fracture of Radius
Recruiting
No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
Distal Radius Fracture, Casting
Active, not recruiting
Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate
Distal Radius Fracture
Recruiting
Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function
Distal Radius Fracture, Colles Fracture
Not yet recruiting
One Inch Punch High Impact Training Randomized Control Trial (1'' Punch HIT RCT)
Distal Radius Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
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. This study is not recruiting at the moment.
Jagar O Doski study chair
University of Duhok
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cast and splint in people with Fracture of Radius, run by University of Duhok at 1 site in Iraq.
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 9 inclusion and 6 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: withdrawn, as of the sponsor's last update on 30 Dec 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 Iraq. 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complication (time frame: up to 12 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 30 Dec 2024.