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Cast Versus Splint in Children With Acceptably Angulated Wrist Fractures

Primary Purpose

Distal Radius Fractures

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Fiberglass short arm cast
Prefabricated wrist splint
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fractures focused on measuring pediatrics, wrist fractures, casting, wrist splint

Eligibility Criteria

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

Inclusion Criteria:

  1. Skeletally immature children.
  2. Children must have a bone age of ≥ 5 years of age.
  3. Less than or equal to 15° angulation in the sagittal plane and ≤ 0.5 cm displacement in the frontal plane.

Therefore, all skeletally immature children ≥ 5 years and with a bone age of ≤ 11 years who present to the ED of HSC with acute distal metaphyseal radius +/- ulnar fractures that meet criteria for acceptable angulation and displacement will be eligible for enrollment.

Exclusion Criteria:

  1. Age < 5 years or > 12
  2. The following diagnoses of distal radius fracture: buckle fracture, growth plate fractures of any kind, distal radius metaphyseal fractures with greater than 15° of angulation in the sagittal plane and/or more than 0.5 cm of displacement in the frontal plane.
  3. All open fractures which require a surgical debridement.
  4. All children at risk for pathological fractures such as those with congenital or acquired generalized bony disease. Stricter immobilization and a different prognosis may be applicable to this population.

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Modified performance Activities Scale for Kids (ASKp) score

Secondary Outcome Measures

Changes in Angulation and/or displacement
Pain
Duration of immobilization device
Grip Strength
Range of Motion
Patient Preference for their Device

Full Information

First Posted
January 24, 2008
Last Updated
October 6, 2017
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT00610220
Brief Title
Cast Versus Splint in Children With Acceptably Angulated Wrist Fractures
Official Title
Cast Versus Splint in Children With Minimally Angulated Fractures of the Distal Radius: a Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study will compare the effectiveness of a prefabricated wrist splint with thermoplast reinforcements versus a short arm cast in skeletally immature children. The hypothesis is that the commercially available wrist splint is at least as effective as traditional casting with respect to recovery of physical function.
Detailed Description
Acceptability angulated wrist bone fractures in children carry an excellent long-term prognosis because of the unique capacity of skeletally immature bones to heal via remodeling. Their management varies widely and there is virtually no scientific evidence supporting one treatment modality over another. Importantly, the most common treatment modality of cast application for four to six weeks is associated with many inconveniences. There are commercially available wrist splints that offer a more convenient alternative. Wrist splints likely have comparable immobilization and symptom relief, while simultaneously allowing for easier bathing and less reliance on subspeciality care. Preliminary adult evidence suggests that, in a comparable adult fracture, splinting may offer a safe alternative to casting, with earlier resumption of the usual activities. However, this treatment modality needs to be compared to the traditional casting management in the pediatric population before it can be recommended for clinical practice. This study will be the first to challenge the current practice of routine casting and compare it to a commercially available wrist splint with respect to recovery of physical function in children with acceptably angulated wrist fractures. In addition, standardized treatment of these fractures with a splint may be associated with lower morbidity, reduced use of health care resources, and have the potential for cost savings. This study will compare, in skeletally immature children, the functional outcomes that result from treatment with a prefabricated wrist splint versus a short arm cast in acceptably angulated distal radius fractures. Secondly, the cost-effectiveness of the splint relative to the cast will be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fractures
Keywords
pediatrics, wrist fractures, casting, wrist splint

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Fiberglass short arm cast
Intervention Description
Cast will be applied for a 4-week period
Intervention Type
Device
Intervention Name(s)
Prefabricated wrist splint
Intervention Description
Splint will be applied for a 4-week period
Primary Outcome Measure Information:
Title
Modified performance Activities Scale for Kids (ASKp) score
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Changes in Angulation and/or displacement
Time Frame
1 and 4 weeks
Title
Pain
Time Frame
1 and 4 weeks
Title
Duration of immobilization device
Time Frame
1 and 4 week follow-up visits
Title
Grip Strength
Time Frame
6 week follow-up visit
Title
Range of Motion
Time Frame
Week 6
Title
Patient Preference for their Device
Time Frame
Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Skeletally immature children. Children must have a bone age of ≥ 5 years of age. Less than or equal to 15° angulation in the sagittal plane and ≤ 0.5 cm displacement in the frontal plane. Therefore, all skeletally immature children ≥ 5 years and with a bone age of ≤ 11 years who present to the ED of HSC with acute distal metaphyseal radius +/- ulnar fractures that meet criteria for acceptable angulation and displacement will be eligible for enrollment. Exclusion Criteria: Age < 5 years or > 12 The following diagnoses of distal radius fracture: buckle fracture, growth plate fractures of any kind, distal radius metaphyseal fractures with greater than 15° of angulation in the sagittal plane and/or more than 0.5 cm of displacement in the frontal plane. All open fractures which require a surgical debridement. All children at risk for pathological fractures such as those with congenital or acquired generalized bony disease. Stricter immobilization and a different prognosis may be applicable to this population.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathy Boutis, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
20823169
Citation
Boutis K, Willan A, Babyn P, Goeree R, Howard A. Cast versus splint in children with minimally angulated fractures of the distal radius: a randomized controlled trial. CMAJ. 2010 Oct 5;182(14):1507-12. doi: 10.1503/cmaj.100119. Epub 2010 Sep 7.
Results Reference
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Cast Versus Splint in Children With Acceptably Angulated Wrist Fractures

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