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A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE): a statistical analyses plan
- Source :
- Trials, Vol 21, Iss 1, Pp 1-13 (2020)
- Publication Year :
- 2020
- Publisher :
- BMC, 2020.
-
Abstract
- Abstract Background We are performing a combined randomised and observational study comparing internal fixation to non-surgical management for common wrist fractures in older patients. This paper describes the statistical analysis plan. Methods/design A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE) is a randomised controlled trial comparing two types of usual care for treating wrist fractures in older patients, surgical fixation using volar locking plates and non-surgical treatment using closed reduction and plaster immobilisation. The primary aim of this comparative-effectiveness study is to determine whether surgery is superior to non-surgical treatment with respect to patient-reported wrist function at 12 months post treatment. The secondary outcomes include radiographic outcomes, complication rates and patient-reported outcomes including quality of life, pain, treatment success and cosmesis. Primary analysis will use a two-sample t test and an intention-to-treat analysis using the randomised arm of the study. Statistical analyses will be two-tailed and significance will be determined by p
Details
- Language :
- English
- ISSN :
- 17456215
- Volume :
- 21
- Issue :
- 1
- Database :
- Directory of Open Access Journals
- Journal :
- Trials
- Publication Type :
- Academic Journal
- Accession number :
- edsdoj.5a92ce10894041a89f9f86a0fcd1cc44
- Document Type :
- article
- Full Text :
- https://doi.org/10.1186/s13063-020-4228-0