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<jats:sec><jats:title>Aims</jats:title><jats:p> Describe a statistical and economic analysis plan for the Distal Radius Acute Fracture Fixation Trial 2 (DRAFFT2) randomized controlled trial. </jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p> DRAFFT2 is a multicentre, parallel, two-arm randomized controlled trial. It compares surgical fixation with K-wires versus plaster cast in adult patients who have sustained a dorsally displaced fracture of the distal radius. The primary outcome measure is the Patient-Rated Wrist Evaluation (PRWE, a validated assessment of wrist function and pain) at 12 months post-randomization. Secondary outcomes are measured at three, six, and 12 months after randomization and include the PWRE, EuroQoL EQ-5D-5L index and EQ-VAS (visual analogue scale), complication rate, and cost-effectiveness of the treatment. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> This paper describes the full details of the planned methods of analysis and descriptive statistics. The DRAFFT2 study protocol has been published previously. </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> The planned analysis strategy described records our intent to conduct statistical and within-trial cost-utility analyses. Cite this article: Bone Joint Open 2020;1-6:245–252. </jats:p></jats:sec>

Original publication

DOI

10.1302/2046-3758.16.bjo-2020-0044.r1

Type

Journal article

Journal

Bone & Joint Open

Publisher

British Editorial Society of Bone & Joint Surgery

Publication Date

06/2020

Volume

1

Pages

245 - 252