A Comparison of Casting and Splinting in Pediatric Radial Buckle Fractures
Primary Purpose
Distal Radial Buckle Fractures
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Volar Splint
Cast
Sponsored by

About this trial
This is an interventional treatment trial for Distal Radial Buckle Fractures focused on measuring fractures, casting, splinting, pediatrics
Eligibility Criteria
Inclusion Criteria:
- 2 - 17 years
- radiographically confirmed distal radial buckle fracture
Exclusion Criteria:
- skeletal maturity
- previous distal radius fracture
- concurrent other fracture
- osteogenesis imperfecta or other metabolic bone disease
Sites / Locations
- St. Louis Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Splint
Cast
Arm Description
Preformed velcro volar splints are compared to traditional circumferential casting.
The circumferential cast is the standard of treatment against which the splint is compared.
Outcomes
Primary Outcome Measures
The primary outcome measure will be the Peds QL questionnaire to assess impact on daily function.
Secondary Outcome Measures
Pain and satisfaction.
Full Information
NCT ID
NCT01010347
First Posted
November 4, 2009
Last Updated
September 22, 2011
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01010347
Brief Title
A Comparison of Casting and Splinting in Pediatric Radial Buckle Fractures
Official Title
A Comparison of Casting and Splinting in Pediatric Radial Buckle Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Background: distal radial buckle fractures are common injuries in children. the ideal immobilization technique is controversial. Few, retrospective studies have been conducted to evaluate bone healing after casting versus splinting. However, the impact of the immobilization technique on daily function and comfort has not been evaluated.
Objective: To compare the impact on daily function, comfort and satisfaction of casting versus splinting in children with distal radial buckle fractures.
Primary Hypothesis: Children with short arm casts to immobilize a distal radial buckle fracture will have a greater reduction in daily activities compared to those immobilized with a volar splint.
Secondary Hypothesis: Children who are immobilized in a short arm cast will have less pain, less patient/parental satisfaction, more adverse effects, fewer follow-up visits, longer emergency department (ED) treatment time. Furthermore, we hypothesize that all fractures will have acceptable alignment/healing at the follow-up orthopaedic clinic evaluation.
Detailed Description
Methods: A randomized controlled trial will be conducted in children 2 to 17 years old with a radio graphically confirmed distal radial buckle fracture. Exclusion criteria will include skeletal maturity, previous distal radius fracture, concurrent other fracture(s), osteogenesis imperfecta or other metabolic bone disease. Enrolled subjects will be randomized to receive either a short arm cast or a volar wrist splint. The pediatric emergency department attending physician will be responsible for applying or directly supervising the immobilization technique. All subjects' radiographs will be reviewed by a pediatric orthopaedic surgeon with 1 day to confirm diagnosis and measure fracture angulation. Those subjects with unacceptable angulation will be called and asked to return to the ED or orthopaedic clinic for re-evaluation.
Outcomes Measures: The primary outcome measure will be the Peds QL questionnaire to assess impact on daily function. This will be assessed at baseline in the ED, by phone at 1 day, 3 days and 1 week after the ED visit, and at the orthopaedic clinic follow-up visit 3 weeks after the ED visit. Secondary outcome measures will include questionnaires assessing demographic data (baseline), pain, satisfaction, adverse effects (baseline, immediately after immobilization applied, 1 day, 3days and 1 week after ED visit by phone, and at the 3 week orthopaedic clinic follow-up visit), and ED treatment time (in ED prior to discharge). At the 3 week orthopaedic surgery clinic follow-up visit, an assessment of the integrity of the immobilization technique will be conducted by a cast technician and fracture alignment/healing and range of motion of affected arm will be conducted by the pediatric orthopaedic surgeon who will be blinded to treatment group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radial Buckle Fractures
Keywords
fractures, casting, splinting, pediatrics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Splint
Arm Type
Active Comparator
Arm Description
Preformed velcro volar splints are compared to traditional circumferential casting.
Arm Title
Cast
Arm Type
Placebo Comparator
Arm Description
The circumferential cast is the standard of treatment against which the splint is compared.
Intervention Type
Procedure
Intervention Name(s)
Volar Splint
Other Intervention Name(s)
Biomed Volar Splint
Intervention Description
A velcro volar splint is compared to a circumferential cast for the treatment of distal radial buckle fractures in children. These are to be worn until Pediatric Orthopaedics follows up with the patients at 3 weeks.
Intervention Type
Procedure
Intervention Name(s)
Cast
Intervention Description
A velcro volar splint is compared to a circumferential cast for the treatment of distal radial buckle fractures in children. These are to be worn until Pediatric Orthopaedics follows up with the patients at 3 weeks.
Primary Outcome Measure Information:
Title
The primary outcome measure will be the Peds QL questionnaire to assess impact on daily function.
Time Frame
Patients are followed for 3 weeks after the initial emergency encounter. They complete the PedsQL and answer questions by telephone.
Secondary Outcome Measure Information:
Title
Pain and satisfaction.
Time Frame
Patients and parents are queried via telephone at days 1, 3, and 7 after the initial emergency visit. They are questioned about pain scores and satisfaction with the immobilization device.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
2 - 17 years
radiographically confirmed distal radial buckle fracture
Exclusion Criteria:
skeletal maturity
previous distal radius fracture
concurrent other fracture
osteogenesis imperfecta or other metabolic bone disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristine Williams, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Louis Children's Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Comparison of Casting and Splinting in Pediatric Radial Buckle Fractures
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