Casting Versus Percutaneus Pinning Treatment of Pediatric Overriding Distal Forearm Fractures

Pediatric Overriding Distal Metaphyseal Radius Fractures Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04323410
• Other study ID #: PediatricOverridingFractures
• Status: Recruiting
• Phase: N/A
• Start date: June 29, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2020
• Source: Töölö Hospital
• Contact: Topi Laaksonen, MD
• Phone: +358 50 427 1654
• Email: topi.laaksonen[@]hus.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Pediatric Overriding Distal Metaphyseal Radius Fractures
• Radius Fractures

Intervention

Procedure:
• Cast immobilization
Cast immobilisation is done using finger trap traction. The fractured forearm is splinted above elbow with dorsal cast without attempted reduction.
• Percutaneus pinning
Reduction under fluoroscopic guidance and fixation using two crossing 1.6mm K-wires.

Locations

Country	Name	City	State
Finland	New Children's Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Töölö Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Forearm ROM	The ratio (injured side/non-injured side) in the total active forearm rotation.	6 months
Secondary	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
Secondary	Patient-reported outcome (PROM)	Quick-DASH, range 0 to 100, 0 best	4 weeks, 3 and 6 months, 1 year
Secondary	Radiographic outcomes	Sagittal and coronal plain radiographs	1 and 4 weeks, 3 and 6 months, 1 year
Secondary	Grip strength	Objective grip strength measurement using dynamometer	3 and 6 months, 1 year
Secondary	Forearms length	Length of forearms and hands	3 and 6 months, 1 year
Secondary	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
Secondary	Forearm ROM	The ratio (injured side/non-injured side) in the total active forearm rotation.	3 months, 1 year
Secondary	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