Long-Arm vs Sugar-Tong (LAST)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Closed Fracture of Shaft of Ulna; Closed Fracture of Shaft of Radius
• Intervention / Treatment: Device: Long-Arm Cast; Device: Sugar-Tong Splint

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • St. Louis Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: Long-Arm Cast; A long-arm cast is a circumferential wrapping of the arm from the fingers to above the elbow with casting material.
Active Comparator: 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.	Device: Sugar-Tong Splint; A sugar-tong splint is the application of hard splinting material on the front and back of the arm.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Publications and helpful links

General Publications

• Bohm ER, Bubbar V, Yong Hing K, Dzus A. Above and below-the-elbow plaster casts for distal forearm fractures in children. A randomized controlled trial. J Bone Joint Surg Am. 2006 Jan;88(1):1-8. doi: 10.2106/JBJS.E.00320.
• Levy J, Ernat J, Song D, Cook JB, Judd D, Shaha S. Outcomes of long-arm casting versus double-sugar-tong splinting of acute pediatric distal forearm fractures. J Pediatr Orthop. 2015 Jan;35(1):11-7. doi: 10.1097/BPO.0000000000000196.
• Kamat AS, Pierse N, Devane P, Mutimer J, Horne G. Redefining the cast index: the optimum technique to reduce redisplacement in pediatric distal forearm fractures. J Pediatr Orthop. 2012 Dec;32(8):787-91. doi: 10.1097/BPO.0b013e318272474d.
• Alemdaroglu KB, Iltar S, Cimen O, Uysal M, Alagoz E, Atlihan D. Risk factors in redisplacement of distal radial fractures in children. J Bone Joint Surg Am. 2008 Jun;90(6):1224-30. doi: 10.2106/JBJS.G.00624.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2019
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: October 22, 2018
• First Submitted That Met QC Criteria: October 26, 2018
• First Posted (Actual): October 30, 2018

Study Record Updates

• Last Update Posted (Actual): October 24, 2019
• Last Update Submitted That Met QC Criteria: October 22, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Closed Reduction; Sugar-Tong Splint; Long-Arm Cast
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Fractures, Closed
• Other Study ID Numbers: 201807196

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes