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

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.

Study Overview

• Status: Withdrawn
• Conditions: Fracture of Radius
• Intervention / Treatment: Device: cast; Device: splint

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Duhok Governorate / Kurdistan Region
    • Duhok, Duhok Governorate / Kurdistan Region, Iraq, 24001
      • Jagar Omar Doski

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: cast group; treatment of the participant of this group will be by the standard method which is by casting	Device: cast; the cast of the upper limb from just below elbow joint to the knuckle of fingers
Experimental: splint group; treatment of the participant of this group will be by the removable splint	Device: splint; Removable splint

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complication	proportion of complication occurrence	up to 12 weeks.

Collaborators and Investigators

• Sponsor: University of Duhok
• Investigators: Study Chair: Jagar O Doski, University of Duhok

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2021
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: January 15, 2022
• First Submitted That Met QC Criteria: February 15, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 26, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: splint; cast
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Wrist Injuries; Wrist Fractures; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: UDuhok

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: personal contact with the investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No