Pediatric Overriding Distal Metaphyseal Radius Fractures Clinical Trial
Official title:
Casting in Finger-trap Traction Without Reduction Versus Closed Reduction and Percutaneous Pin Fixation of Dorsally Displaced, Overriding Distal Metaphyseal Radius Fractures in Under Eleven Years Old Children
This is a randomized controlled trial comparing casting in finger-trap traction without reduction versus closed reduction and percutaneous pin fixation of dorsally displaced, overriding distal metaphyseal radius fractures in under eleven years old children.
Overriding pediatric distal radius fractures have been managed with anatomical reduction
performed under anesthesia with or without percutaneous pinning. This research protocol was
developed due to good results reported on leaving the fractures in an overriding position.
In this randomized controlled trial, we will compare objective outcomes between casting in
finger-trap traction without reduction versus closed reduction and percutaneous pin fixation
of dorsally displaced, overriding distal metaphyseal radius fractures in children.
Inclusion criteria are patients younger than 11 years old (Tanner 0) with completely
overriding distal radius fractures. At the emergency department patients are randomized into
two groups: finger trap traction and cast immobilization (experimental group) and anatomic
reduction and percutaneous pin fixation (control group).
The current controversy is whether cast immobilization alone is an adequate stabilization or
whether percutaneous pin fixation is more appropriate for displaced, complete, distal forearm
(overriding) metaphyseal fractures. The objectives of this trial are to compare the outcomes
between conservative treatment with finger trap method for completely displaced distal radius
fractures and surgical treatment with percutaneous pinning. Our null hypothesis is that there
are no radiological or clinically relevant differences in outcome measures between the two
treatment groups. We consider non-inferiority proven if there is no clinically significant
difference at 6 months between the two treatments groups in the primary outcome: ratio (%) of
forearm rotation and wrist extension-flexion range of motion (ROM) compared to the
non-affected side at 6 months (non-inferiority margin 10%).
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