New Children's Hospital
Helsinki, Finland
Location status: Recruiting
NCT Number: NCT04323410
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.
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Request InfoUp to 10 year
All sexes
Interventional
Not applicable
Helsinki, Finland
Location status: Recruiting
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%).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 6 months
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
The ratio (injured side/non-injured side) in the total active forearm rotation.
Time frame: 1 and 4 weeks, 3 and 6 months, 1 year
Pain at rest and in activities is assessed on PedsQL questionnaire. Range 0 to 100 mm, 0 best.
Time frame: 4 weeks, 3 and 6 months, 1 year
Quick-DASH, range 0 to 100, 0 best
Time frame: 1 and 4 weeks, 3 and 6 months, 1 year
Sagittal and coronal plain radiographs
Time frame: 3 and 6 months, 1 year
Objective grip strength measurement using dynamometer
Time frame: 3 and 6 months, 1 year
Length of forearms and hands
Time frame: 3 months, 1 year
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
The ratio (injured side/non-injured side) in the total active forearm rotation.
Time frame: 6 months
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.
Contact information is provided by the study sponsor or research team.
Töölö Hospital
Other
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
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