Cast Versus Splint in Children With Acceptably Angulated Wrist Fractures

• ClinicalTrials.gov Identifier: NCT00610220
• Recruitment Status: Completed
• First Posted: February 7, 2008
• Last Update Posted: October 9, 2017
• Sponsor: The Hospital for Sick Children
• Information provided by (Responsible Party): Kathy Boutis, The Hospital for Sick Children

Tracking Information

• First Submitted Date: January 24, 2008
• First Posted Date: February 7, 2008
• Last Update Posted Date: October 9, 2017
• Study Start Date: January 2007
• Actual Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 24, 2008): Modified performance Activities Scale for Kids (ASKp) score [ Time Frame: 6 weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 26, 2010)

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

Original Secondary Outcome Measures (submitted: January 24, 2008)

• Changes in Angulation and/or displacement [ Time Frame: 1 and 4 weeks ]
• Pain [ Time Frame: At time of injury and once a week for 4 weeks ]
• Duration of immobilization device [ Time Frame: 1 and 4 week follow-up visits ]
• Grip Strength [ Time Frame: 6 week follow-up visit ]
• Range of Motion [ Time Frame: 4 weeks ]
• Time to return to full painless baseline activities [ Time Frame: Time frame determined by outcome ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.

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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Distal Radius Fractures

Intervention

• 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

Study Arms

• Active Comparator: 1
  Intervention: Device: Fiberglass short arm cast
• Experimental: 2
  Intervention: Device: Prefabricated wrist splint

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 8, 2010): 96
• Original Estimated Enrollment (submitted: January 24, 2008): 76
• Actual Study Completion Date: October 2009
• Actual Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 5 Years to 12 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT00610220
• Other Study ID Numbers: 1000010377
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Kathy Boutis, The Hospital for Sick Children
• Original Responsible Party: Kathy Boutis/Principal Investigator, The Hospital for Sick Children
• Current Study Sponsor: The Hospital for Sick Children
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Kathy Boutis, MD; The Hospital for Sick Children

• PRS Account: The Hospital for Sick Children
• Verification Date: May 2014