Cast Versus Splint in Children With Acceptably Angulated Wrist Fractures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kathy Boutis, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00610220
First received: January 24, 2008
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Distal Radius Fractures
Device: Fiberglass short arm cast
Device: Prefabricated wrist splint
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cast Versus Splint in Children With Minimally Angulated Fractures of the Distal Radius: a Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Modified performance Activities Scale for Kids (ASKp) score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in Angulation and/or displacement [ Time Frame: 1 and 4 weeks ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: 1 and 4 weeks ] [ Designated as safety issue: No ]
  • Duration of immobilization device [ Time Frame: 1 and 4 week follow-up visits ] [ Designated as safety issue: No ]
  • Grip Strength [ Time Frame: 6 week follow-up visit ] [ Designated as safety issue: No ]
  • Range of Motion [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Patient Preference for their Device [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Enrollment: 96
Study Start Date: January 2007
Study Completion Date: October 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Device: Fiberglass short arm cast
Cast will be applied for a 4-week period
Experimental: 2 Device: Prefabricated wrist splint
Splint will be applied for a 4-week period

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.

  Eligibility

Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610220

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Kathy Boutis, MD The Hospital for Sick Children
  More Information

Publications:
Responsible Party: Kathy Boutis, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00610220     History of Changes
Other Study ID Numbers: 1000010377
Study First Received: January 24, 2008
Last Updated: May 12, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
pediatrics
wrist fractures
casting
wrist splint

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Arm Injuries
Forearm Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014