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%).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Cast immobilisation is done using finger trap traction. The fractured forearm is splinted above elbow with dorsal cast without attempted reduction.
Reduction under fluoroscopic guidance and fixation using two crossing 1.6mm K-wires.
New Children's Hospital
Helsinki, Finland
RECRUITINGWrist ROM
The ratio (injured side/non-injured side) in total active range of motion of the wrist in the flexion-extension plane.
Time frame: 6 months
Forearm ROM
The ratio (injured side/non-injured side) in the total active forearm rotation.
Time frame: 6 months
Patient-reported pain
Pain at rest and in activities is assessed on PedsQL questionnaire. Range 0 to 100 mm, 0 best.
Time frame: 1 and 4 weeks, 3 and 6 months, 1 year
Patient-reported outcome (PROM)
Quick-DASH, range 0 to 100, 0 best
Time frame: 4 weeks, 3 and 6 months, 1 year
Radiographic outcomes
Sagittal and coronal plain radiographs
Time frame: 1 and 4 weeks, 3 and 6 months, 1 year
Grip strength
Objective grip strength measurement using dynamometer
Time frame: 3 and 6 months, 1 year
Forearms length
Length of forearms and hands
Time frame: 3 and 6 months, 1 year
Wrist ROM
The ratio (injured side/non-injured side) in total active range of motion of the wrist in the flexion-extension plane.
Time frame: 3 months, 1 year
Forearm ROM
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The ratio (injured side/non-injured side) in the total active forearm rotation.
Time frame: 3 months, 1 year
Overall satisfaction
The patient's parent(s) or guardian(s) are queried about their satisfaction with the treatment. The satisfaction of the function of the fractured upper extremity and its effect on the patient's daily living and satisfaction to the cosmetic outcome are recorded on a 5-step Likert scale.
Time frame: 6 months