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

Primary Purpose

Fracture of Radius

Status
Recruiting
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
cast
splint
Sponsored by
University of Duhok
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fracture of Radius focused on measuring splint, cast

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jagar Omar DoskiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

cast group

splint group

Arm Description

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

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

Outcomes

Primary Outcome Measures

complication
proportion of complication occurrence

Secondary Outcome Measures

Full Information

First Posted
January 15, 2022
Last Updated
February 15, 2022
Sponsor
University of Duhok
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1. Study Identification

Unique Protocol Identification Number
NCT05244317
Brief Title
Removable Splint Versus Cast in the Treatment of Distal Radius Fracture in Children
Official Title
Removable Splint Versus Cast in the Treatment of Distal Radius Fracture in Children of Refugees' Camps: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2021 (Actual)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Duhok

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture of Radius
Keywords
splint, cast

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
146 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cast group
Arm Type
Placebo Comparator
Arm Description
treatment of the participant of this group will be by the standard method which is by casting
Arm Title
splint group
Arm Type
Experimental
Arm Description
treatment of the participant of this group will be by the removable splint
Intervention Type
Device
Intervention Name(s)
cast
Intervention Description
the cast of the upper limb from just below elbow joint to the knuckle of fingers
Intervention Type
Device
Intervention Name(s)
splint
Intervention Description
Removable splint
Primary Outcome Measure Information:
Title
complication
Description
proportion of complication occurrence
Time Frame
up to 12 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jagar O Doski, MD
Phone
+9647504594137
Email
jagaromar@uod.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jagar O Doski
Organizational Affiliation
University of Duhok
Official's Role
Study Chair
Facility Information:
Facility Name
Jagar Omar Doski
City
Duhok
State/Province
Duhok Governorate / Kurdistan Region
ZIP/Postal Code
24001
Country
Iraq
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jagar O Doski
Phone
07504594137
Email
jagaromar@uod.ac

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
personal contact with the investigator

Learn more about this trial

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

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