Casting Versus Percutaneus Pinning Treatment of Pediatric Overriding Distal Forearm Fractures

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Overriding Distal Metaphyseal Radius Fractures
• Intervention / Treatment: Procedure: Cast immobilization; Procedure: Percutaneus pinning

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%).

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Topi Laaksonen, MD; Phone Number: +358 50 427 1654; Email: topi.laaksonen@hus.fi

Study Locations

• Finland
  • Helsinki, Finland
    • Recruiting
    • New Children's Hospital
    • Contact: Topi Laaksonen, MD; Phone Number: +358 50 427 1654; Email: topi.laaksonen@hus.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 10 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cast immobilization; In the casting group, padded synthetic dorsal above elbow and volar below elbow splints are applied in ED without local or general anesthesia. Dorsal displacement and shortening of the radius are not corrected, but the forearm is attempted to be manipulated straight during application of the splints. The casted forearm is then supported by a collar and cuff sling. Splints are removed in an outpatient clinic at 4 weeks. Cast immobilization is discontinued after 4 weeks and when the fracture site is nontender. If palpated tenderness is still present, the patient is given a dorsal forearm splint which can be removed (maximum of 2 weeks usage).	Procedure: Cast immobilization; Cast immobilisation is done using finger trap traction. The fractured forearm is splinted above elbow with dorsal cast without attempted reduction.
ACTIVE_COMPARATOR: Percutaneus pinning; In the surgery group, a padded dorsal above elbow splint is applied in ED. Reduction and percutaneous pinning are performed under anesthesia in operating room by an experienced attending pediatric orthopedic surgeon within 7 days from the injury. Pin fixation is performed with two 1.6 mm pins. Padded dorsal above elbow and volar below elbow splints are applied. Splints and pins are removed at the outpatient clinic at 4 weeks after surgery.	Procedure: Percutaneus pinning; Reduction under fluoroscopic guidance and fixation using two crossing 1.6mm K-wires.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Forearm ROM	The ratio (injured side/non-injured side) in the total active forearm rotation.	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Töölö Hospital

Publications and helpful links

General 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-2020-045689.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 29, 2020
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2025

Study Registration Dates

• First Submitted: March 24, 2020
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (ACTUAL): March 26, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 1, 2020
• Last Update Submitted That Met QC Criteria: June 29, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: bayonet fracture; paediatric fracture; distal forearm fracture; overriding fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: PediatricOverridingFractures

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No