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

Sponsor
University of Duhok (Other)
Overall Status
Recruiting
CT.gov ID
NCT05244317
Collaborator
(none)
146
1
2
21.3
6.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: cast
  • Device: splint
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
146 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Removable Splint Versus Cast in the Treatment of Distal Radius Fracture in Children of Refugees' Camps: a Randomized Controlled Trial
Actual Study Start Date :
Sep 20, 2021
Anticipated Primary Completion Date :
May 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. complication [up to 12 weeks.]

    proportion of complication occurrence

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jagar Omar Doski Duhok Duhok Governorate / Kurdistan Region Iraq 24001

Sponsors and Collaborators

  • University of Duhok

Investigators

  • Study Chair: Jagar O Doski, University of Duhok

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jagar Omar Doski, Assistant Professor of Orthopedics, University of Duhok
ClinicalTrials.gov Identifier:
NCT05244317
Other Study ID Numbers:
  • UDuhok
First Posted:
Feb 17, 2022
Last Update Posted:
Feb 17, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jagar Omar Doski, Assistant Professor of Orthopedics, University of Duhok
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 17, 2022