Statistical and health economic analysis plan for a randomized controlled trial of surgical fixation with K-wires versus plaster casting in the treatment of dorsally displaced distal radius fractures: DRAFFT2.

ABSTRACT:

Aims

Describe a statistical and economic analysis plan for the Distal Radius Acute Fracture Fixation Trial 2 (DRAFFT2) randomized controlled trial.

Methods

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.

Results

This paper

SUBMITTER: Ooms AG 

PROVIDER: S-EPMC7677726 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature