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

NCT05244317 | Withdrawn

• 1 other identifier: UDuhok
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. Hence, it may be valuable to find simple, cheap, and safe methods of treatment for their injuries.

Conditions

Fracture of Radius

Keywords

splint; cast

Outcome Measures

Primary Outcomes (1)

• complication

  proportion of complication occurrence

  up to 12 weeks.

Study Arms (2)

cast group

PLACEBO COMPARATOR

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

Device: cast

splint group

EXPERIMENTAL

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

Device: splint

Interventions

cast DEVICE

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

cast group

splint DEVICE

Removable splint

splint group

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Duhok: lead

Study Sites (1)

Jagar Omar Doski

Duhok, Duhok Governorate / Kurdistan Region, 24001, Iraq

Location

MeSH Terms

Conditions

Radius Fractures

Interventions

Casts, Surgical; Splints

Condition Hierarchy (Ancestors)

Forearm Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Officials

• Jagar O Doski

  University of Duhok

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopedics

Study Record Dates

• First Submitted: January 15, 2022
• First Posted: February 17, 2022
• Study Start: September 20, 2021
• Primary Completion: May 30, 2023
• Study Completion: June 30, 2023
• Last Updated: December 30, 2024

Record last verified: 2024-12

Locations

IR (1)