Pediatric Overriding Distal Metaphyseal Radius Fractures
Conditions
Keywords
bayonet fracture, paediatric fracture, distal forearm fracture, overriding fracture
Brief summary
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.
Detailed description
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%).
Interventions
PROCEDURECast immobilization
Cast immobilisation is done using finger trap traction. The fractured forearm is splinted above elbow with dorsal cast without attempted reduction.
PROCEDUREPercutaneus pinning
Reduction under fluoroscopic guidance and fixation using two crossing 1.6mm K-wires.
Sponsors
Töölö Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Non-inferiority randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
No minimum to 10 Years
Healthy volunteers
No
Inclusion criteria
* Child with open epiphysis with closed overriding metaphyseal distal radial fracture with or without an associated fracture of the ulna * Normal communication development (languages Finnish, Swedish, English)
Exclusion criteria
* Bilateral forearm injuries * Gustillo-Anderson grade II or III open fracture * Galeazzi fracture-dislocation * Polytrauma * Neurovascular injury of the ipsilateral upper extremity * History of a displaced forearm fracture * Underlying disease affecting fracture healing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wrist ROM | 6 months | The ratio (injured side/non-injured side) in total active range of motion of the wrist in the flexion-extension plane. |
| Forearm ROM | 6 months | The ratio (injured side/non-injured side) in the total active forearm rotation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported pain | 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. |
| Patient-reported outcome (PROM) | 4 weeks, 3 and 6 months, 1 year | Quick-DASH, range 0 to 100, 0 best |
| Radiographic outcomes | 1 and 4 weeks, 3 and 6 months, 1 year | Sagittal and coronal plain radiographs |
| Grip strength | 3 and 6 months, 1 year | Objective grip strength measurement using dynamometer |
| Forearms length | 3 and 6 months, 1 year | Length of forearms and hands |
| Wrist ROM | 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. |
| Forearm ROM | 3 months, 1 year | The ratio (injured side/non-injured side) in the total active forearm rotation. |
| Overall satisfaction | 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. |
Countries
Finland
Contacts
CONTACTTopi Laaksonen, MD
Outcome results
None listed