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Casting Versus Percutaneus Pinning Treatment of Pediatric Overriding Distal Forearm Fractures

Primary Purpose

Pediatric Overriding Distal Metaphyseal Radius Fractures

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Cast immobilization
Percutaneus pinning
Sponsored by
Töölö Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Overriding Distal Metaphyseal Radius Fractures focused on measuring bayonet fracture, paediatric fracture, distal forearm fracture, overriding fracture

Eligibility Criteria

undefined - 10 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • New Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cast immobilization

Percutaneus pinning

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient-reported pain
Pain at rest and in activities is assessed on PedsQL questionnaire. Range 0 to 100 mm, 0 best.
Patient-reported outcome (PROM)
Quick-DASH, range 0 to 100, 0 best
Radiographic outcomes
Sagittal and coronal plain radiographs
Grip strength
Objective grip strength measurement using dynamometer
Forearms length
Length of forearms and hands
Wrist ROM
The ratio (injured side/non-injured side) in total active range of motion of the wrist in the flexion-extension plane.
Forearm ROM
The ratio (injured side/non-injured side) in the total active forearm rotation.
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.

Full Information

First Posted
March 24, 2020
Last Updated
June 29, 2020
Sponsor
Töölö Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04323410
Brief Title
Casting Versus Percutaneus Pinning Treatment of Pediatric Overriding Distal Forearm Fractures
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Töölö Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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%).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Overriding Distal Metaphyseal Radius Fractures
Keywords
bayonet fracture, paediatric fracture, distal forearm fracture, overriding fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Non-inferiority randomized controlled trial
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cast immobilization
Arm Type
Experimental
Arm Description
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).
Arm Title
Percutaneus pinning
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Cast immobilization
Intervention Description
Cast immobilisation is done using finger trap traction. The fractured forearm is splinted above elbow with dorsal cast without attempted reduction.
Intervention Type
Procedure
Intervention Name(s)
Percutaneus pinning
Intervention Description
Reduction under fluoroscopic guidance and fixation using two crossing 1.6mm K-wires.
Primary Outcome Measure Information:
Title
Wrist ROM
Description
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
Title
Forearm ROM
Description
The ratio (injured side/non-injured side) in the total active forearm rotation.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Patient-reported pain
Description
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
Title
Patient-reported outcome (PROM)
Description
Quick-DASH, range 0 to 100, 0 best
Time Frame
4 weeks, 3 and 6 months, 1 year
Title
Radiographic outcomes
Description
Sagittal and coronal plain radiographs
Time Frame
1 and 4 weeks, 3 and 6 months, 1 year
Title
Grip strength
Description
Objective grip strength measurement using dynamometer
Time Frame
3 and 6 months, 1 year
Title
Forearms length
Description
Length of forearms and hands
Time Frame
3 and 6 months, 1 year
Title
Wrist ROM
Description
The ratio (injured side/non-injured side) in total active range of motion of the wrist in the flexion-extension plane.
Time Frame
3 months, 1 year
Title
Forearm ROM
Description
The ratio (injured side/non-injured side) in the total active forearm rotation.
Time Frame
3 months, 1 year
Title
Overall satisfaction
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Topi Laaksonen, MD
Phone
+358 50 427 1654
Email
topi.laaksonen@hus.fi
Facility Information:
Facility Name
New Children's Hospital
City
Helsinki
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Topi Laaksonen, MD
Phone
+358 50 427 1654
Email
topi.laaksonen@hus.fi

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34039573
Citation
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.
Results Reference
derived

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Casting Versus Percutaneus Pinning Treatment of Pediatric Overriding Distal Forearm Fractures

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