Is Casting of Displaced Pediatric Distal Forearm Fractures Non-inferior to Reduction in General Anesthesia?
NCT ID: NCT05736068
Last Updated: 2025-01-27
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
NA
Total Enrollment
40 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-09-07
Study Completion Date
2026-01-31
Brief Summary
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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.
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.
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Detailed Description
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Pediatric distal forearm fractures (DFF) are very common and accounts for 25-30% of all fractures in children.(1,2) Up to half of all pediatric DFF are displaced to an extent where surgery has been the preferred treatment option.(3) However, surgery does come with a cost.
The most common treatment of displaced pediatric DFF has long been closed reduction with or without pin fixation (or in rare cases plate and screw fixation) under general anesthesia, followed by immobilization in a cast.(4) Pin-related complications vary from 4-23%, depending on what is reported as complications,(5-11) and up to 40% has been reported when including re-displacements.(12) The insertion of a metal wire or plate also requires subsequent procedures to remove these implants again.
Numerous small cohort studies and case series have found pin fixation advantageous in achieving anatomic reduction and avoiding re-displacement.(5-11) However, whether anatomic reduction and stabilization is important regarding the patient-reported functional outcome has not been investigated since most studies use only radiographic or objective measures (e.g. range of motion). In addition, children's bones, and in particular the metaphysis and epiphysis, have a unique ability to heal and remodel throughout the growth period until puberty.(13) Almost 20 years ago, Do et al. (14) stated that "the tremendous capacity of distal metaphyseal radius fractures to heal and remodel makes this one of the most rewarding fractures to treat non-operatively. \[…\]". In accordance with Do et al., other studies indicate that displaced DFF fractures in prepubertal children might heal without manipulation, and that most displaced fractures will remodel within a year or two to almost anatomical position with no functional impairment.(14-17) Although most surgeons are aware that children's bones have this remodeling potential, they still find it challenging to deal with the uncertainty of whether the bone will actually remodel to an acceptable position. Furthermore, surgeons might have difficulties with how families will react to the waiting time until the misaligned arm looks normal again.
If non-surgical treatment of displaced pediatric DFF were more common, the costs associated with surgery could be minimized. Unfortunately, there is limited evidence to guide the decision to operate or not. The available studies are typically small, retrospective cohort studies or case series of low quality with no predefined follow-up or outcome measures. To our knowledge, there are no published randomized controlled trials (RCTs) comparing non-surgical treatment with surgical treatment, and no studies report outcomes from the patient's perspective.
The aim of this trial is to investigate the patient-reported functional outcome after non-surgical treatment of displaced DFF in children aged 4-10 years. Our hypothesis is, that casting without manipulation is non-inferior to surgical treatment.
The most common treatment of displaced pediatric DFF has long been closed reduction with or without pin fixation (or in rare cases plate and screw fixation) under general anesthesia, followed by immobilization in a cast.(4) Pin-related complications vary from 4-23%, depending on what is reported as complications,(5-11) and up to 40% has been reported when including re-displacements.(12) The insertion of a metal wire or plate also requires subsequent procedures to remove these implants again.
Numerous small cohort studies and case series have found pin fixation advantageous in achieving anatomic reduction and avoiding re-displacement.(5-11) However, whether anatomic reduction and stabilization is important regarding the patient-reported functional outcome has not been investigated since most studies use only radiographic or objective measures (e.g. range of motion). In addition, children's bones, and in particular the metaphysis and epiphysis, have a unique ability to heal and remodel throughout the growth period until puberty.(13) Almost 20 years ago, Do et al. (14) stated that "the tremendous capacity of distal metaphyseal radius fractures to heal and remodel makes this one of the most rewarding fractures to treat non-operatively. \[…\]". In accordance with Do et al., other studies indicate that displaced DFF fractures in prepubertal children might heal without manipulation, and that most displaced fractures will remodel within a year or two to almost anatomical position with no functional impairment.(14-17) Although most surgeons are aware that children's bones have this remodeling potential, they still find it challenging to deal with the uncertainty of whether the bone will actually remodel to an acceptable position. Furthermore, surgeons might have difficulties with how families will react to the waiting time until the misaligned arm looks normal again.
If non-surgical treatment of displaced pediatric DFF were more common, the costs associated with surgery could be minimized. Unfortunately, there is limited evidence to guide the decision to operate or not. The available studies are typically small, retrospective cohort studies or case series of low quality with no predefined follow-up or outcome measures. To our knowledge, there are no published randomized controlled trials (RCTs) comparing non-surgical treatment with surgical treatment, and no studies report outcomes from the patient's perspective.
The aim of this trial is to investigate the patient-reported functional outcome after non-surgical treatment of displaced DFF in children aged 4-10 years. Our hypothesis is, that casting without manipulation is non-inferior to surgical treatment.
Conditions
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Distal Forearm Fracture
Distal Radius Fracture
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
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.
Study Groups
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Non-surgical
No reduction. Application of a cast.
Group Type
EXPERIMENTAL
Non-surgical treatment
Intervention Type
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.
Surgical
Closed reduction under general anesthesia with or without additional pin fixation of surgeons' choice followed by cast immobilization.
Group Type
ACTIVE_COMPARATOR
Surgical treatment
Intervention Type
PROCEDURE
Closed reduction with or without fixation
Interventions
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Non-surgical treatment
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.
Intervention Type
PROCEDURE
Surgical treatment
Closed reduction with or without fixation
Intervention Type
PROCEDURE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
* 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
Minimum Eligible Age
4 Years
Maximum Eligible Age
10 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Aalborg University Hospital
OTHER
Sponsor Role
collaborator
Aarhus University Hospital
OTHER
Sponsor Role
collaborator
Odense University Hospital
OTHER
Sponsor Role
collaborator
Zealand University Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Katrine Rønn Abildgaard
MD, PhD student
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Stig Brorson, MD PhD DMSc
Role: STUDY_DIRECTOR
Zealand University Hospital
Katrine R. Abildgaard, MD
Role: PRINCIPAL_INVESTIGATOR
Zealand University Hospital
Locations
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Aalborg University Hospital
Aalborg, , Denmark
Site Status
Aarhus University Hospital
Aarhus, , Denmark
Site Status
Zealand University Hospital
Køge, , Denmark
Site Status
Odense University Hospital
Odense, , Denmark
Site Status
Countries
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Denmark
References
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Phelps EE, Tutton E, Costa ML, Achten J, Moscrop A, Perry DC. Protecting my injured child: a qualitative study of parents' experience of caring for a child with a displaced distal radius fracture. BMC Pediatr. 2022 May 12;22(1):270. doi: 10.1186/s12887-022-03340-z.
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BACKGROUND
Abildgaard KR, Buxbom P, Rahbek O, Gottliebsen M, Gundtoft PH, Viberg B, Brorson S. Is casting of displaced paediatric distal forearm fractures non-inferior to reduction under general anaesthesia? Study protocol for a pragmatic, randomized, controlled non-inferiority multicentre trial (the casting trial). Trials. 2024 Jun 27;25(1):420. doi: 10.1186/s13063-024-08253-z.
Reference Type
DERIVED
Other Identifiers
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REG-099-2022
Identifier Type: -
Identifier Source: org_study_id
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