Long-Arm vs Sugar-Tong

Study Overview
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Brief Summary
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The purpose of this study is to determine whether a sugar-tong splint is as effective as a long-arm cast in maintaining reduction of pediatric forearm shaft fractures in a randomized, prospective manner. Consented participants will be randomly assigned to be treated with either a sugar-tong splint or a long-arm cast (both standard of care treatments) in REDCap. Each participant will have a 50/50 chance of being assign to either treatment.

Detailed Description
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Forearm fractures are very common in the pediatric population and can often be treated with closed reduction and immobilization. Immobilization techniques include long-arm casting, short-arm casting and sugar-tong splinting. At the time of injury casts are usually split into two using a cast saw, known as bivalving, to allow for swelling and are overwrapped at a later time. By design sugar-tong splints allow for swelling and are overwrapped or converted to a cast at a later time. Traditionally long-arm casts have been used as the standard mode of immobilization for forearm fractures. Recent evidence demonstrates that long-arm casting is equivalent to better tolerated short-arm casting as an immobilization choice for distal third forearm fractures.1 Further work has shown that sugar-tong splints are also appropriate for treatment of distal third forearm fractures. No study has compared the efficacy of using a long-arm cast versus a sugar-tong splint for treatment of forearm shaft fractures.

Official Title
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Outcomes of Long-Arm Casting Versus Sugar-Tong Splinting of Displaced Forearm Shaft Fractures

Conditions
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Closed Fracture of Shaft of Ulna, Closed Fracture of Shaft of Radius

Intervention / Treatment
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* Device: Long-Arm Cast
* Device: Sugar-Tong Splint


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Single or both bone forearm shaft fractures, follow-up at the St. Louis Children's Hospital and affiliated branches Exclusion Criteria: Children below 4 or above 12 years of age Distal radius/ulna fracture(s) Distal radius/ulna third shaft fracture(s) Proximal radius/ulna third shaft fracture(s) Radius/ulna fracture(s) not requiring reduction Open radius/ulna fracture(s) Radius/ulna fracture(s) requiring open reduction in the operating room Patient with metabolic defects Pathologic radius/ulna fracture(s) Previous fractures in the same location (radius/ulna)

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Long-Arm Cast<br>Reduction and long-arm cast application will be performed by PGY-1 and up residents with adequate training and/or supervision in the required techniques. | Device: Long-Arm Cast<br>* A long-arm cast is a circumferential wrapping of the arm from the fingers to above the elbow with casting material.<br>|
| Active Comparator: Sugar-Tong Splint<br>Reduction and sugar-tong splint application will be performed by PGY-1 and up residents with adequate training and/or supervision in the required techniques. | Device: Sugar-Tong Splint<br>* A sugar-tong splint is the application of hard splinting material on the front and back of the arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic measurements | Measure sagittal angulation | 1 week | 
| Radiographic measurements | Measure sagittal angulation | 2 weeks | 
| Radiographic measurements | Measure sagittal angulation | 4 weeks | 
| Radiographic measurements | Measure sagittal angulation | 6 weeks | 
| Radiographic measurements | Coronal angulation | 1 week | 
| Radiographic measurements | Coronal angulation | 2 weeks | 
| Radiographic measurements | Coronal angulation | 4 weeks | 
| Radiographic measurements | Coronal angulation | 6 weeks | 
| Radiographic measurements | Displacement | 1 week | 
| Radiographic measurements | Displacement | 2 weeks | 
| Radiographic measurements | Displacement | 4 weeks | 
| Radiographic measurements | Displacement | 6 weeks | 
| Radiographic measurements | Percent displacement | 1 week | 
| Radiographic measurements | Percent displacement | 2 weeks | 
| Radiographic measurements | Percent displacement | 4 weeks | 
| Radiographic measurements | Percent displacement | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical follow-up | Treatment information | 1 week | 
| Clinical follow-up | Treatment information | 2 weeks | 
| Clinical follow-up | Treatment information | 4 weeks | 
| Clinical follow-up | Treatment information | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Closed Reduction, Sugar-Tong Splint, Long-Arm Cast