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NCT Number: NCT04323410

Casting Versus Percutaneus Pinning Treatment of Pediatric Overriding Distal Forearm Fractures

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.

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Key information

Age range

Up to 10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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%).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cast immobilization

Procedure

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

Percutaneus pinning

Procedure

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

Primary outcomes

  1. Wrist ROM

    Time frame: 6 months

    The ratio (injured side/non-injured side) in total active range of motion of the wrist in the flexion-extension plane.

  2. Forearm ROM

    Time frame: 6 months

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

Secondary outcomes

  1. Patient-reported pain

    Time frame: 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.

  2. Patient-reported outcome (PROM)

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

    Quick-DASH, range 0 to 100, 0 best

  3. Radiographic outcomes

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

    Sagittal and coronal plain radiographs

  4. Grip strength

    Time frame: 3 and 6 months, 1 year

    Objective grip strength measurement using dynamometer

  5. Forearms length

    Time frame: 3 and 6 months, 1 year

    Length of forearms and hands

  6. Wrist ROM

    Time frame: 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.

  7. Forearm ROM

    Time frame: 3 months, 1 year

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

  8. Overall satisfaction

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Topi Laaksonen, MD

CONTACT

[email protected]

+358 50 427 1654

Sponsors and collaborators

Lead sponsor

Töölö Hospital

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2025
Study completion
2027
First posted
Mar 26, 2020
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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