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Long-Arm vs Sugar-Tong (LAST)

Primary Purpose

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

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Long-Arm Cast
Sugar-Tong Splint
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Closed Fracture of Shaft of Ulna focused on measuring Closed Reduction, Sugar-Tong Splint, Long-Arm Cast

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • St. Louis Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Long-Arm Cast

Sugar-Tong Splint

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Radiographic measurements
Measure sagittal angulation
Radiographic measurements
Measure sagittal angulation
Radiographic measurements
Measure sagittal angulation
Radiographic measurements
Measure sagittal angulation
Radiographic measurements
Coronal angulation
Radiographic measurements
Coronal angulation
Radiographic measurements
Coronal angulation
Radiographic measurements
Coronal angulation
Radiographic measurements
Displacement
Radiographic measurements
Displacement
Radiographic measurements
Displacement
Radiographic measurements
Displacement
Radiographic measurements
Percent displacement
Radiographic measurements
Percent displacement
Radiographic measurements
Percent displacement
Radiographic measurements
Percent displacement

Secondary Outcome Measures

Clinical follow-up
Treatment information
Clinical follow-up
Treatment information
Clinical follow-up
Treatment information
Clinical follow-up
Treatment information

Full Information

First Posted
October 22, 2018
Last Updated
October 22, 2019
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03724773
Brief Title
Long-Arm vs Sugar-Tong
Acronym
LAST
Official Title
Outcomes of Long-Arm Casting Versus Sugar-Tong Splinting of Displaced Forearm Shaft Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Decided not to enroll
Study Start Date
March 2019 (Anticipated)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Closed Fracture of Shaft of Ulna, Closed Fracture of Shaft of Radius
Keywords
Closed Reduction, Sugar-Tong Splint, Long-Arm Cast

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Long-Arm Cast
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sugar-Tong Splint
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Long-Arm Cast
Intervention Description
A long-arm cast is a circumferential wrapping of the arm from the fingers to above the elbow with casting material.
Intervention Type
Device
Intervention Name(s)
Sugar-Tong Splint
Intervention Description
A sugar-tong splint is the application of hard splinting material on the front and back of the arm.
Primary Outcome Measure Information:
Title
Radiographic measurements
Description
Measure sagittal angulation
Time Frame
1 week
Title
Radiographic measurements
Description
Measure sagittal angulation
Time Frame
2 weeks
Title
Radiographic measurements
Description
Measure sagittal angulation
Time Frame
4 weeks
Title
Radiographic measurements
Description
Measure sagittal angulation
Time Frame
6 weeks
Title
Radiographic measurements
Description
Coronal angulation
Time Frame
1 week
Title
Radiographic measurements
Description
Coronal angulation
Time Frame
2 weeks
Title
Radiographic measurements
Description
Coronal angulation
Time Frame
4 weeks
Title
Radiographic measurements
Description
Coronal angulation
Time Frame
6 weeks
Title
Radiographic measurements
Description
Displacement
Time Frame
1 week
Title
Radiographic measurements
Description
Displacement
Time Frame
2 weeks
Title
Radiographic measurements
Description
Displacement
Time Frame
4 weeks
Title
Radiographic measurements
Description
Displacement
Time Frame
6 weeks
Title
Radiographic measurements
Description
Percent displacement
Time Frame
1 week
Title
Radiographic measurements
Description
Percent displacement
Time Frame
2 weeks
Title
Radiographic measurements
Description
Percent displacement
Time Frame
4 weeks
Title
Radiographic measurements
Description
Percent displacement
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Clinical follow-up
Description
Treatment information
Time Frame
1 week
Title
Clinical follow-up
Description
Treatment information
Time Frame
2 weeks
Title
Clinical follow-up
Description
Treatment information
Time Frame
4 weeks
Title
Clinical follow-up
Description
Treatment information
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16391243
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. doi: 10.2106/JBJS.E.00320.
Results Reference
background
PubMed Identifier
24787302
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.
Results Reference
background
PubMed Identifier
23147621
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.
Results Reference
background
PubMed Identifier
18519314
Citation
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.
Results Reference
background

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Long-Arm vs Sugar-Tong

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