Long-Arm vs Sugar-Tong

Not Applicable

Withdrawn

• Conditions: Closed Fracture of Shaft of Ulna; Closed Fracture of Shaft of Radius
• Interventions: Device: Sugar-Tong Splint; Device: Long-Arm Cast

• Registration Number: NCT03724773
• Lead Sponsor: Washington University School of Medicine

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 Timeline

• Study First Submitted: 2018-10-22
• Study First Submitted QC: 2018-10-26
• Study First Posted: 2018-10-30
• Study Start: 2019-03
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-22
• Last Update Posted: 2019-10-24
• Primary Completion: 2020-05
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Single or both bone forearm shaft fractures, follow-up at the St. Louis Children's Hospital and affiliated branches

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugar-Tong Splint	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.
Long-Arm Cast	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.

Primary Outcome Measures

Name	Time	Method
Radiographic measurements	6 weeks	Percent displacement

Secondary Outcome Measures

Name	Time	Method
Clinical follow-up	6 weeks	Treatment information

Trial Locations

Locations (1)

St. Louis Children's Hospital; 🇺🇸 Saint Louis, Missouri, United States