Cast Versus Splint in Children With Acceptably Angulated Wrist Fractures

NCT00610220 | Completed Phase 4 DMC

• 1 other identifier: 1000010377
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Distal Radius Fractures

Keywords

pediatrics; wrist fractures; casting; wrist splint

Outcome Measures

Primary Outcomes (1)

• Modified performance Activities Scale for Kids (ASKp) score

  6 weeks

Secondary Outcomes (6)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

Device: Fiberglass short arm cast

2

EXPERIMENTAL

Device: Prefabricated wrist splint

Interventions

Fiberglass short arm cast DEVICE

Cast will be applied for a 4-week period

1

Prefabricated wrist splint DEVICE

Splint will be applied for a 4-week period

2

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

Related Publications (1)

• 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.

  PMID: 20823169 RESULT

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Kathy Boutis, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: January 24, 2008
• First Posted: February 7, 2008
• Study Start: January 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: October 1, 2009
• Last Updated: October 9, 2017

Record last verified: 2014-05

Locations

CA (1)