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Removable Splint Versus Cast in the Treatment of Distal Radius Fracture in Children

NCT ID: NCT05244317

Last Updated: 2024-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-20

Study Completion Date

2023-06-30

Brief Summary

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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

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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

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Fracture of Radius

Keywords

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splint cast

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cast group

treatment of the participant of this group will be by the standard method which is by casting

Group Type PLACEBO_COMPARATOR

cast

Intervention Type DEVICE

the cast of the upper limb from just below elbow joint to the knuckle of fingers

splint group

treatment of the participant of this group will be by the removable splint

Group Type EXPERIMENTAL

splint

Intervention Type DEVICE

Removable splint

Interventions

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cast

the cast of the upper limb from just below elbow joint to the knuckle of fingers

Intervention Type DEVICE

splint

Removable splint

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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:

* 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.

Exclusion Criteria

* open fractures
* pathological fractures
* displaced fractures that need reduction
* delayed presentation beyond 7 days
* associated fracture of the ulnar bone
* polytraumatic cases.
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Duhok

OTHER

Sponsor Role lead

Responsible Party

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Jagar Omar Doski

Assistant Professor of Orthopedics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jagar O Doski

Role: STUDY_CHAIR

University of Duhok

Locations

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Jagar Omar Doski

Dihok, Duhok Governorate / Kurdistan Region, Iraq

Site Status

Countries

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Iraq

Other Identifiers

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UDuhok

Identifier Type: -

Identifier Source: org_study_id