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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Prospective, Randomized, Multi-Center Pilot Study on the Treatment of Unstable, Extraarticular Colles Fractures of the Distal Radius by Palmar Locking Plate, External Fixa

Brief Summary:

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.


Detailed Summary:
Sponsor: Heinrich-Heine University, Duesseldorf

Current Primary Outcome: Functional status measured by DASH questionnaire

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pain
  • Range of motion (ROM)
  • Grip strength
  • Radiological parameters
  • Feasibility


Original Secondary Outcome: Same as current

Information By: Heinrich-Heine University, Duesseldorf

Dates:
Date Received: January 3, 2006
Date Started: November 2005
Date Completion:
Last Updated: April 25, 2007
Last Verified: April 2007