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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.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00610220
Enrollment
96
Registered
2008-02-07
Start date
2007-01-31
Completion date
2009-10-31
Last updated
2017-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal Radius Fractures

Keywords

pediatrics, wrist fractures, casting, wrist splint

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.

Interventions

DEVICEFiberglass short arm cast

Cast will be applied for a 4-week period

DEVICEPrefabricated wrist splint

Splint will be applied for a 4-week period

Sponsors

The Hospital for Sick Children
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Modified performance Activities Scale for Kids (ASKp) score6 weeks

Secondary

MeasureTime frame
Pain1 and 4 weeks
Duration of immobilization device1 and 4 week follow-up visits
Changes in Angulation and/or displacement1 and 4 weeks
Range of MotionWeek 6
Patient Preference for their DeviceWeek 6
Grip Strength6 week follow-up visit

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026