Randomized Trial of Casting Techniques for Displaced Forearm Fractures

Study Overview
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Brief Summary
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It is recognized that fractures of the distal radius and forearm occur in approximately one in 100 children and adolescents every year. Though closed manipulation and cast immobilization of displaced injuries is the mainstay of treatment in the majority of cases, the optimal type of cast remains debatable. Though well-molded casts theoretically provide the best ability to maintain fracture alignment, risks of circumferential immobilization in acute injuries include neurovascular compromise. Splitting, or bivalving, casts may reduce these risks, but the effect on fracture stability is unknown. The proposed investigation seeks to address the simple question of whether circumferential or bivalved casts provide the best outcomes.

Official Title
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Randomized Trial of Bivalved and Circumferential Casting for Displaced Forearm Fractures in Children

Conditions
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Displaced Forearm Fractures

Intervention / Treatment
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* Other: Bivalved cast
* Other: Circumferential cast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Displaced distal radius or mid-diaphyseal forearm fracture fracture requires closed reduction and cast immobilization Age 4-16 years Skeletally immature Exclusion Criteria: Failed closed reduction Acute fracture > 1 week old Refracture injury Fracture requires surgical treatment Significant soft tissue swelling Associated neurovascular compromise Plastic deformation injuries

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bivalved cast<br>Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast | Other: Bivalved cast<br>* Circumferential cast will be applied following closed reduction and then bivalved using a cast saw<br>|
| Active Comparator: Circumferential cast<br>Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast | Other: Circumferential cast<br>* Circumferential cast will be applied following closed reduction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loss of Radius Fracture Reduction | The number of participants that experienced radiographic loss of reduction by four weeks post-randomization. | 4 weeks post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compartment Syndrome or Neurovascular Compromise, Saw Burns and/or Lacerations | The number of participants that experienced compartment syndrome or neurovascular compromise, saw burn and/or laceration within four weeks post-randomization. | Up to 4 weeks post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Casting techniques, Bivalved cast, Circumferential cast, Displaced distal radius fracture, Children