Casting Versus Percutaneus Pinning Treatment of Pediatric Overriding Distal Forearm Fractures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cast immobilization, Percutaneus pinning.
- Who it may be relevant to
- Registry conditions: Pediatric Overriding Distal Metaphyseal Radius Fractures. Basic parameters: up to 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
- Procedure Cast immobilization
Cast immobilisation is done using finger trap traction. The fractured forearm is splinted above elbow with dorsal cast without attempted reduction. - Procedure Percutaneus pinning
Reduction under fluoroscopic guidance and fixation using two crossing 1.6mm K-wires.
Primary outcome measures
- Wrist ROM [Time frame: 6 months]
- Forearm ROM [Time frame: 6 months]
Secondary outcome measures (8)
- Patient-reported pain [Time frame: 1 and 4 weeks, 3 and 6 months, 1 year]
- Patient-reported outcome (PROM) [Time frame: 4 weeks, 3 and 6 months, 1 year]
- Radiographic outcomes [Time frame: 1 and 4 weeks, 3 and 6 months, 1 year]
- Grip strength [Time frame: 3 and 6 months, 1 year]
- Forearms length [Time frame: 3 and 6 months, 1 year]
- Wrist ROM [Time frame: 3 months, 1 year]
- Forearm ROM [Time frame: 3 months, 1 year]
- Overall satisfaction [Time frame: 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Finland · 1 center
- New Children's Hospital — Helsinki
Publications
- 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-2 PMID 34039573
Identifiers
NCT: NCT04323410 · PediatricOverridingFractures