Casting Versus Percutaneus Pinning Treatment of Pediatric Overriding Distal Forearm Fractures

Sponsor

Töölö Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04323410

Collaborator

(none)

Enrollment

Location

Arms

66.1

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric Overriding Distal Metaphyseal Radius Fractures	Procedure: Cast immobilization Procedure: Percutaneus pinning	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Non-inferiority randomized controlled trialNon-inferiority randomized controlled trial

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 29, 2020

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Wrist ROM [6 months]
The ratio (injured side/non-injured side) in total active range of motion of the wrist in the flexion-extension plane.
Forearm ROM [6 months]
The ratio (injured side/non-injured side) in the total active forearm rotation.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New Children's Hospital	Helsinki		Finland

Sponsors and Collaborators

Töölö Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Topi Laaksonen, Principal Investigator, Helsinki University Central Hospital

ClinicalTrials.gov Identifier:

NCT04323410

Other Study ID Numbers:

PediatricOverridingFractures

First Posted:

Mar 26, 2020

Last Update Posted:

Jul 1, 2020

Last Verified:

Jun 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Topi Laaksonen, Principal Investigator, Helsinki University Central Hospital

bayonet fracture

paediatric fracture

distal forearm fracture

overriding fracture

Additional relevant MeSH terms:

Fractures, Bone

Radius Fractures

Study Results

No Results Posted as of Jul 1, 2020