Casting Versus Percutaneus Pinning Treatment of Pediatric Overriding Distal Forearm Fractures

Study Overview
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Brief Summary
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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
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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%).

Official Title
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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

Conditions
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Pediatric Overriding Distal Metaphyseal Radius Fractures

Intervention / Treatment
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* Procedure: Cast immobilization
* Procedure: Percutaneus pinning


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Non-inferiority randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cast immobilization<br>In the casting group, padded synthetic dorsal above elbow and volar below elbow splints are applied in ED without local or general anesthesia. Dorsal displacement and shortening of the radius are not corrected, but the forearm is attempted to be manipulated straight during application of the splints. The casted forearm is then supported by a collar and cuff sling. Splints are removed in an outpatient clinic at 4 weeks. Cast immobilization is discontinued after 4 weeks and when the fracture site is nontender. If palpated tenderness is still present, the patient is given a dorsal forearm splint which can be removed (maximum of 2 weeks usage). | Procedure: Cast immobilization<br>* Cast immobilisation is done using finger trap traction. The fractured forearm is splinted above elbow with dorsal cast without attempted reduction.<br>|
| Active Comparator: Percutaneus pinning<br>In the surgery group, a padded dorsal above elbow splint is applied in ED. Reduction and percutaneous pinning are performed under anesthesia in operating room by an experienced attending pediatric orthopedic surgeon within 7 days from the injury. Pin fixation is performed with two 1.6 mm pins. Padded dorsal above elbow and volar below elbow splints are applied. Splints and pins are removed at the outpatient clinic at 4 weeks after surgery. | Procedure: Percutaneus pinning<br>* Reduction under fluoroscopic guidance and fixation using two crossing 1.6mm K-wires.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wrist ROM | The ratio (injured side/non-injured side) in total active range of motion of the wrist in the flexion-extension plane. | 6 months | 
| Forearm ROM | The ratio (injured side/non-injured side) in the total active forearm rotation. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported pain | Pain at rest and in activities is assessed on PedsQL questionnaire. Range 0 to 100 mm, 0 best. | 1 and 4 weeks, 3 and 6 months, 1 year | 
| Patient-reported outcome (PROM) | Quick-DASH, range 0 to 100, 0 best | 4 weeks, 3 and 6 months, 1 year | 
| Radiographic outcomes | Sagittal and coronal plain radiographs | 1 and 4 weeks, 3 and 6 months, 1 year | 
| Grip strength | Objective grip strength measurement using dynamometer | 3 and 6 months, 1 year | 
| Forearms length | Length of forearms and hands | 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. | 3 months, 1 year | 
| Forearm ROM | The ratio (injured side/non-injured side) in the total active forearm rotation. | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bayonet fracture, paediatric fracture, distal forearm fracture, overriding fracture