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

Sponsor

Zealand University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05736068

Collaborator

Aalborg University Hospital (Other), Aarhus University Hospital (Other), Odense University Hospital (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Distal Forearm Fracture Distal Radius Fracture	Procedure: Non-surgical treatment Procedure: Surgical treatment	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

Is CASTING of Displaced Pediatric Distal Forearm Fractures Non-inferior to Reduction in General Anesthesia? A Pragmatic, Randomized, Controlled Non-inferiority Multicenter Trial

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Non-surgical No reduction. Application of a cast.	Procedure: 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.
Active Comparator: Surgical Closed reduction under general anesthesia with or without additional pin fixation of surgeons' choice followed by cast immobilization.	Procedure: Surgical treatment Closed reduction with or without fixation

Arm

Intervention/Treatment

Experimental: Non-surgical

No reduction. Application of a cast.

Procedure: 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.

Active Comparator: Surgical

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

Procedure: Surgical treatment

Closed reduction with or without fixation

Outcome Measures

Primary Outcome Measures

QuickDASH [12 months]
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.

Secondary Outcome Measures

QuickDASH [3 and 6 months]
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.
EQ-5D-Y [3, 6 and 12 months]
Health-related quality of life. The questionnaire consists of two parts: the descriptive system which assesses health in five dimensions (Mobility; Looking After Myself; Doing Usual Activities; Having Pain or Discomfort; Feeling Worried, Sad or Unhappy). A visual analogue scale (VAS) on which the respondent rates their perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health)
Wong-Baker Faces Pain Rating Scale (WBS) [3, 6 and 12 months]
A self-reported tool to assess pain using a series of six facial expressions to illustrate the degree of pain intensity.

Other Outcome Measures

Radiographs (explorative outcome) [6 and 12 months]
Evaluation of the remodeling process. No statistical analysis will be made.
Photographs (explorative outcome) [3, 6 and 12 months]
Observation of the cosmetic progress and to be used for documentation of what future patients can expect cosmetically.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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