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Clinical Trials/NCT03724773
NCT03724773WithdrawnNot Applicable

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

Washington University School of Medicine1 site in 1 countryStarted: March 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
1
Primary Endpoint
Radiographic measurements

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
4 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

Long-Arm Cast

Active Comparator

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.

Intervention: Long-Arm Cast (Device)

Sugar-Tong Splint

Active Comparator

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.

Intervention: Sugar-Tong Splint (Device)

Outcomes

Primary Outcomes

Radiographic measurements

Time Frame: 6 weeks

Measure sagittal angulation

Radiographic measurements

Time Frame: 1 week

Measure sagittal angulation

Radiographic measurements

Time Frame: 4 weeks

Measure sagittal angulation

Radiographic measurements

Time Frame: 2 weeks

Measure sagittal angulation

Secondary Outcomes

  • Clinical follow-up(6 weeks)
  • Clinical follow-up(1 week)
  • Clinical follow-up(2 weeks)
  • Clinical follow-up(4 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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