Cast Versus Splint in Children With Acceptably Angulated Wrist Fractures

This study has been completed.
Sponsor:
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00610220
First received: January 24, 2008
Last updated: October 26, 2010
Last verified: October 2010

January 24, 2008
October 26, 2010
January 2007
July 2009   (final data collection date for primary outcome measure)
Modified performance Activities Scale for Kids (ASKp) score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00610220 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Changes in Angulation and/or displacement [ Time Frame: 1 and 4 weeks ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: At time of injury and once a week for 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: 4 weeks ] [ Designated as safety issue: No ]
  • Time to return to full painless baseline activities [ Time Frame: Time frame determined by outcome ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Distal Radius Fractures
  • Device: Fiberglass short arm cast
    Cast will be applied for a 4-week period
  • Device: Prefabricated wrist splint
    Splint will be applied for a 4-week period
  • Active Comparator: 1
    Intervention: Device: Fiberglass short arm cast
  • Experimental: 2
    Intervention: Device: Prefabricated wrist splint
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. Epub 2010 Sep 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
96
October 2009
July 2009   (final data collection date for primary outcome measure)

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.
Both
5 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00610220
1000010377
Yes
Kathy Boutis/Principal Investigator, The Hospital for Sick Children
The Hospital for Sick Children
Not Provided
Principal Investigator: Kathy Boutis, MD The Hospital for Sick Children
The Hospital for Sick Children
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP