Is Casting of Displaced Pediatric Distal Forearm Fractures Non-inferior to Reduction in General Anesthesia?

NCT05736068 | Active Not Recruiting DMC

• 1 other identifier: REG-099-2022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief Summary

Treatment of displaced distal forearm fractures (DFF) in children have traditionally been closed reduction and pin fixation, although they might heal and remodel without manipulation, with no functional impairment. No randomized controlled trials (RCTs) have been published comparing the patient-reported functional outcome after non-surgical and surgical treatment of displaced DFF in children. This is a multicentre RCT. The aim of the trial is to investigate the patient-reported functional outcome after non-surgical treatment of displaced distal forearm fractures (DFF) in children. We will include 44 children aged 4-10 years with a displaced DFF. They will be offered inclusion, if the on-duty orthopedic surgeon finds indication for surgical intervention. If the parents/guardians consent to participate, the children will be allocated equally to non-surgical treatment (intervention) or surgical treatment of surgeon's choice (comparator). We will follow the children during one year, where they will be seen after 4 weeks, 3, 6 and 12 months. The primary outcome is the between-group difference in 12 months Quick Disabilities Arm Shoulder and Hand (QuickDASH) score.

Conditions

Distal Forearm Fracture; Distal Radius Fracture

Keywords

Forearm injuries; Wrist injuries; Salter-Harris fractures; Closed fracture reduction; Child; Bone remodeling

Outcome Measures

Primary Outcomes (1)

• QuickDASH

  Reporting of disability experienced and monitoring changes in symptoms and function over time. The patient (with help by parents if the patient is too young to self-report) rates each item according to the perceived degree of severity using a 5-point Likert Scale. Then, the overall score is transformed to a score between 0 and 100 (0 = no disability, 100 = maximum disability) according to the algorithm \[(sum of responses N/N)-1\]\*25, where N is equal to the number of responses.

  12 months

Secondary Outcomes (3)

• QuickDASH

  3 and 6 months

• EQ-5D-Y

  3, 6 and 12 months

• Wong-Baker Faces Pain Rating Scale (WBS)

  3, 6 and 12 months

Other Outcomes (2)

• Radiographs (explorative outcome)

  6 and 12 months

• Photographs (explorative outcome)

  3, 6 and 12 months

Study Arms (2)

Non-surgical

EXPERIMENTAL

No reduction. Application of a cast.

Procedure: Non-surgical treatment

Surgical

ACTIVE COMPARATOR

Closed reduction under general anesthesia with or without additional pin fixation of surgeons' choice followed by cast immobilization.

Procedure: Surgical treatment

Interventions

Non-surgical treatment PROCEDURE

If allocated to non-surgical group, cast optimization in the outpatient clinic may be necessary if the cast from the emergency room is considered insufficient.

Non-surgical

Surgical treatment PROCEDURE

Closed reduction with or without fixation

Surgical

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children 4-10 years of age with open physes
• Fractures in the distal metaphyseal radius (with or without concomitant ulna fracture), including extraarticular physeal fractures (SH I-II)
• Overriding fractures
• Angulated fractures of 20-40°
• The on-duty surgeon finds reduction under anesthesia with or without fixation indicated

You may not qualify if:

• Open fractures
• Nerve or vascular affection
• All intraarticular fractures including SH III-V
• Ulnar physeal fractures
• Polytrauma
• Concomitant ipsi- or contralateral upper extremity fractures (except distal ulna fracture)
• Pathologic fractures
• The injury is \>7 days old
• Other conditions that may affect bone healing

Sponsors & Collaborators

• Zealand University Hospital: lead
• Aalborg University Hospital: collaborator
• Aarhus University Hospital: collaborator
• Odense University Hospital: collaborator

Study Sites (4)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Zealand University Hospital

Køge, 4600, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (38)

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MeSH Terms

Conditions

Wrist Fractures; Forearm Injuries; Wrist Injuries; Salter-Harris Fractures

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries; Fractures, Bone; Fracture Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Stig Brorson, MD PhD DMSc

  Zealand University Hospital

  STUDY DIRECTOR

• Katrine R. Abildgaard, MD

  Zealand University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patient-Reported Outcome Measure (PROM) scores and radiographs will be evaluated by persons, who are blinded to treatment allocation and who are not otherwise involved in the study. Data analysis will be performed by an external biostatistician blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD student

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: February 21, 2023
• Study Start: September 7, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (4)