Cast Versus Splint in Children With Acceptably Angulated Wrist Fractures
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|ClinicalTrials.gov Identifier: NCT00610220|
Recruitment Status : Completed
First Posted : February 7, 2008
Last Update Posted : October 9, 2017
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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 or disease||Intervention/treatment||Phase|
|Distal Radius Fractures||Device: Fiberglass short arm cast Device: Prefabricated wrist splint||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Cast Versus Splint in Children With Minimally Angulated Fractures of the Distal Radius: a Randomized Controlled Trial.|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||October 2009|
|Active Comparator: 1||
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
- Modified performance Activities Scale for Kids (ASKp) score [ Time Frame: 6 weeks ]
- 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 ]
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|Ages Eligible for Study:||5 Years to 12 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00610220
|The Hospital for Sick Children|
|Toronto, Ontario, Canada|
|Principal Investigator:||Kathy Boutis, MD||The Hospital for Sick Children|
|Responsible Party:||Kathy Boutis, Staff Physician, The Hospital for Sick Children|
|Other Study ID Numbers:||
|First Posted:||February 7, 2008 Key Record Dates|
|Last Update Posted:||October 9, 2017|
|Last Verified:||May 2014|
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