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Casting Versus Percutaneus Pinning Treatment of Pediatric Overriding Distal Forearm Fractures

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ClinicalTrials.gov Identifier: NCT04323410
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
Topi Laaksonen, Helsinki University Central Hospital

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 Not Applicable

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%).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Non-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 : June 29, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   up to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04323410


Contacts
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Contact: Topi Laaksonen, MD +358 50 427 1654 topi.laaksonen@hus.fi

Locations
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Finland
New Children's Hospital Recruiting
Helsinki, Finland
Contact: Topi Laaksonen, MD    +358 50 427 1654    topi.laaksonen@hus.fi   
Sponsors and Collaborators
Töölö Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Topi Laaksonen, Principal Investigator, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT04323410    
Other Study ID Numbers: PediatricOverridingFractures
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Topi Laaksonen, Helsinki University Central Hospital:
bayonet fracture
paediatric fracture
distal forearm fracture
overriding fracture
Additional relevant MeSH terms:
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Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries