Clinical trial NCT04323410: Casting Versus Percutaneus Pinning Treatment of Pediatric Overriding Distal Forearm Fractures
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Overriding Distal Metaphyseal Radius Fractures
Keywords: bayonet fracture
paediatric fracture
distal forearm fracture
overriding fracture
Lead sponsor: Töölö Hospital
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 60
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-inferiority randomized controlled trial
Primary purpose: TREATMENT

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%).

Eligibility criteria: 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

Primary outcomes:
measure: Wrist ROM
timeFrame: 6 months
measure: Forearm ROM
timeFrame: 6 months
Secondary outcomes:
measure: Patient-reported pain
timeFrame: 1 and 4 weeks, 3 and 6 months, 1 year
measure: Patient-reported outcome (PROM)
timeFrame: 4 weeks, 3 and 6 months, 1 year
measure: Radiographic outcomes
timeFrame: 1 and 4 weeks, 3 and 6 months, 1 year
measure: Grip strength
timeFrame: 3 and 6 months, 1 year
measure: Forearms length
timeFrame: 3 and 6 months, 1 year
measure: Wrist ROM
timeFrame: 3 months, 1 year
measure: Forearm ROM
timeFrame: 3 months, 1 year
measure: Overall satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: New Children's Hospital
Study officials:
References:
citation: Laaksonen T, Stenroos A, Puhakka J, Kosola J, Kautiainen H, Ramo L, Nietosvaara Y. Casting in finger trap traction without reduction versus closed reduction and percutaneous pin fixation of dorsally displaced, over-riding distal metaphyseal radius fractures in children under 11 years old: a study protocol of a randomised controlled trial. BMJ Open. 2021 May 26;11(5):e045689. doi: 10.1136/bmjopen-2020-045689.