Trial of Ultrasound Guidance for Reduction of Pediatric Forearm Fractures

This will be a prospective randomized, controlled, single blinded study that will take place
at the Children's Hospital at Montefiore (CHAM) in the Pediatric Emergency Department (PED).
Patients who present to the PED, are confirmed to have a forearm fracture requiring closed
reduction in the PED and meet the inclusion/exclusion criteria will be eligible for the
study. The decision to perform a closed reduction procedure in the PED will be made by the
consulting orthopedic surgeon who will perform the procedure. All eligible patients' pain
will be reassessed and managed as necessary as per standard of care The eligible patient or
parent/guardian will be approached by the treating physician or consulting orthopedic
resident for written consent. Written assent will be obtained from minors older than 7 years
of age. After enrollment into the study, patients will be randomized to either the
experimental group (ultrasound guided fracture reduction) or control group (standard of care
forearm fracture reduction without real-time imaging). Allocation of patients to
intervention and control arms will be accomplished by a computer-generated permuted block
randomization scheme.

Consulting orthopedic residents will be trained to perform musculoskeletal sonography for
this study and will be considered study-trained physicians. All patients will undergo
procedural sedation and/or pain management for closed reduction as per standard of care in
the PED. The medication used for sedation and/or pain will be determined by the treating PEM
physician. Study patients that are randomized to the ultrasound guided group will undergo a
point-of-care ultrasound, performed by a study trained physician using a Sonosite Edge
ultrasound machine with an L38 linear 10-5 MHz transducer probe.

Prior to the reduction procedure in patients randomized to the experimental group,
ultrasound images of the fracture site will be obtained and the maximum degree of
displacement will be measured. Both longitudinal and transverse views of the injured area
will be obtained. The trained physician will then perform real-time ultrasound imaging as
needed during the closed reduction procedure. Once the orthopedic resident determines that
he/she has obtained optimal alignment and prior to casting, a post-reduction ultrasound
image will be obtained and the angle of displacement will again be measured. All ultrasounds
performed prior to and after the reduction will be recorded, and the images obtained will
include video clips of the ultrasound as well as a saved still picture of the best image of
the suspected fracture site. The study-trained physician who performed the ultrasound will
then record his/her findings on the data collection form immediately after the procedure and
prior to reviewing plain radiographs.

While it has been our experience that the majority of reduction procedures performed in the
PED are done without the use of any real time imaging, some orthopedic surgery residents
employ the use of the c-arm (fluoroscopy) and/or a portable x-ray machine during the
reduction procedure. At his/her discretion, the orthopedic resident may use either of these
modalities in both the ultrasound and control group as per standard of care in the PED. The
use of these modalities will be recorded.

After the reduction procedure in the ultrasound group and prior to reviewing the post
reduction x-ray, the orthopedic resident will complete a brief questionnaire. Patients in
both groups will then undergo a post-reduction x-ray. Based on the degree of displacement on
the x-ray, the orthopedic surgeon will determine whether the patient needs a repeat
reduction, as per routine standard of care. If a repeat reduction is required, the treating
physician can choose to use ultrasound at his/her disgression. The angle of displacement
will be measured on the post-reduction x-ray by an orthopedic surgeon. Additionally, the
angle of displacement measured on the post-reduction ultrasound will be measured and
compared to the angle of displacement on the post-reduction x-ray. An expert sonographer
will review cases where the ultrasound and x-ray results do not correlate.

Inclusion Criteria:

- Patients who present to the Pediatric Emergency Department (PED) with a confirmed
displaced forearm fracture that will require reduction by orthopedic surgery in the
PED will be eligible for inclusion in this study.

Exclusion Criteria:

1. Patients with open fractures.

2. Patients with neurovascular compromise.

3. Unstable patients with life-threatening injuries who require ongoing resuscitation.