Long-Arm vs Sugar-Tong

Closed Fracture of Shaft of Radius Clinical Trial

— LAST  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03724773
• Other study ID #: 201807196
• Status: Withdrawn
• Phase: N/A
• Start date: March 2019
• Est. completion date: September 2020

Study information

• Verified date: October 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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)

Related Conditions & MeSH terms

• Closed Fracture of Shaft of Radius
• Closed Fracture of Shaft of Ulna
• Fractures, Bone
• Fractures, Closed

Intervention

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

Locations

Country	Name	City	State
United States	St. Louis Children's Hospital	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (4)

Alemdaroglu KB, Iltar S, Cimen O, Uysal M, Alagöz 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic measurements	Measure sagittal angulation	1 week
Primary	Radiographic measurements	Measure sagittal angulation	2 weeks
Primary	Radiographic measurements	Measure sagittal angulation	4 weeks
Primary	Radiographic measurements	Measure sagittal angulation	6 weeks
Primary	Radiographic measurements	Coronal angulation	1 week
Primary	Radiographic measurements	Coronal angulation	2 weeks
Primary	Radiographic measurements	Coronal angulation	4 weeks
Primary	Radiographic measurements	Coronal angulation	6 weeks
Primary	Radiographic measurements	Displacement	1 week
Primary	Radiographic measurements	Displacement	2 weeks
Primary	Radiographic measurements	Displacement	4 weeks
Primary	Radiographic measurements	Displacement	6 weeks
Primary	Radiographic measurements	Percent displacement	1 week
Primary	Radiographic measurements	Percent displacement	2 weeks
Primary	Radiographic measurements	Percent displacement	4 weeks
Primary	Radiographic measurements	Percent displacement	6 weeks
Secondary	Clinical follow-up	Treatment information	1 week
Secondary	Clinical follow-up	Treatment information	2 weeks
Secondary	Clinical follow-up	Treatment information	4 weeks
Secondary	Clinical follow-up	Treatment information	6 weeks