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Casting Versus Percutaneus Pinning Treatment of Pediatric Overriding Distal Forearm Fractures

ConditionPediatric Overriding Distal Metaphyseal Radius Fractures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 10
SponsorTöölö Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Bilateral forearm injuries

Gustillo-Anderson grade II or III open fracture

Galeazzi fracture-dislocation

Polytrauma

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cast immobilization

    Procedure/Surgery

    Cast immobilisation is done using finger trap traction. The fractured forearm is splinted above elbow with dorsal cast without attempted reduction.

  • Percutaneus pinning

    Procedure/Surgery

    Reduction under fluoroscopic guidance and fixation using two crossing 1.6mm K-wires.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Cast immobilizationExperimental treatment 1 intervention
Group B: Percutaneus pinningActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Wrist ROM

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
2

Forearm ROM

The ratio (injured side/non-injured side) in the total active forearm rotation.

Time frame
6 months

Secondary outcomes

1

Patient-reported pain

Pain at rest and in activities is assessed on PedsQL questionnaire. Range 0 to 100 mm, 0 best.

Time frame
1 and 4 weeks, 3 and 6 months, 1 year
2

Patient-reported outcome (PROM)

Quick-DASH, range 0 to 100, 0 best

Time frame
4 weeks, 3 and 6 months, 1 year
3

Radiographic outcomes

Sagittal and coronal plain radiographs

Time frame
1 and 4 weeks, 3 and 6 months, 1 year
4

Grip strength

Objective grip strength measurement using dynamometer

Time frame
3 and 6 months, 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Töölö Hospital

Lead sponsor

Helsinki University Central Hospital

Sponsor institution

Source ClinicalTrials.gov
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