Operative Treatment of Extraarticular Colles' Fractures of the Distal Radius (OTEC)

Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2005
This is a prospective, randomized, multi-center pilot study of unstable extraarticular fractures of the distal radius with dorsal displacement of the distal fragment in elderly patients. The patients are randomly assigned to osteosynthesis with palmar locking plate, external fixator, or Kirschner wires. The aim of this pilot study is to allow a sample size calculation for a main randomized controlled trial (RCT). The primary outcome criterion is the functional status measured by the Disability of the Arm, Shoulder and Hand (DASH) questionnaire. Secondary outcome criteria are pain, range of motion (ROM), grip strength, and radiological parameters. Since this is a pilot study it is intended to generate a study hypothesis for the main RCT.
Epistemonikos ID: babbac12cf72db65ca45b5bbb83461528d0e9df2
First added on: May 04, 2024