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| Tracking Information | |||||
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| First Received Date ICMJE | January 24, 2008 | ||||
| Last Updated Date | May 22, 2008 | ||||
| Start Date ICMJE | January 2007 | ||||
| Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Modified performance Activities Scale for Kids (ASKp) score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00610220 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cast Versus Splint in Children With Acceptably Angulated Wrist Fractures | ||||
| Official Title ICMJE | Randomized Controlled Trial of Cast Versus Splint in Children With Acceptably Angulated Wrist Fractures | ||||
| 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. |
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| 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. |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Distal Radius Fractures | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 76 | ||||
| Estimated Completion Date | October 2009 | ||||
| Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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:
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| Gender | Both | ||||
| Ages | 5 Years to 14 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00610220 | ||||
| Responsible Party | Kathy Boutis/Principal Investigator, The Hospital for Sick Children | ||||
| Study ID Numbers ICMJE | 1000010377 | ||||
| Study Sponsor ICMJE | The Hospital for Sick Children | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | The Hospital for Sick Children | ||||
| Verification Date | May 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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