Clinical trial NCT05244317: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Fracture of Radius
Keywords: splint
cast
Lead sponsor: University of Duhok
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: complication
timeFrame: up to 12 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Duhok
country: Iraq
facility: Jagar Omar Doski
state: Duhok Governorate / Kurdistan Region
Study officials:
affiliation: University of Duhok
name: Jagar O Doski
role: STUDY_CHAIR
References: