Long-Arm vs Sugar-Tong

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-31

Study Completion Date

2020-09-30

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.

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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.

Conditions

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Closed Fracture of Shaft of Ulna Closed Fracture of Shaft of Radius

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Long-Arm Cast

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.

Group Type ACTIVE_COMPARATOR

Long-Arm Cast

Intervention Type DEVICE

A long-arm cast is a circumferential wrapping of the arm from the fingers to above the elbow with casting material.

Sugar-Tong Splint

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.

Group Type ACTIVE_COMPARATOR

Sugar-Tong Splint

Intervention Type DEVICE

A sugar-tong splint is the application of hard splinting material on the front and back of the arm.

Interventions

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Long-Arm Cast

A long-arm cast is a circumferential wrapping of the arm from the fingers to above the elbow with casting material.

Intervention Type DEVICE

Sugar-Tong Splint

A sugar-tong splint is the application of hard splinting material on the front and back of the arm.

Intervention Type DEVICE

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)

Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No