Cast Versus Splint in Children With Acceptably Angulated Wrist Fractures

Cast Versus Splint in Children With Minimally Angulated Fractures of the Distal Radius: a Randomized Controlled Trial.

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.

Study Overview

• Status: Completed
• Conditions: Distal Radius Fractures
• Intervention / Treatment: Device: Fiberglass short arm cast; Device: Prefabricated wrist splint

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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2	Device: Prefabricated wrist splint; Splint will be applied for a 4-week period
Active Comparator: 1	Device: Fiberglass short arm cast; Cast will be applied for a 4-week period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Modified performance Activities Scale for Kids (ASKp) score	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in Angulation and/or displacement	1 and 4 weeks
Pain	1 and 4 weeks
Duration of immobilization device	1 and 4 week follow-up visits
Grip Strength	6 week follow-up visit
Range of Motion	Week 6
Patient Preference for their Device	Week 6

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: January 24, 2008
• First Submitted That Met QC Criteria: January 24, 2008
• First Posted (Estimate): February 7, 2008

Study Record Updates

• Last Update Posted (Actual): October 9, 2017
• Last Update Submitted That Met QC Criteria: October 6, 2017
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: pediatrics; wrist fractures; casting; wrist splint
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: 1000010377