NCT00271726

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

Prospective, Randomized, Multi-Center Pilot Study on the Treatment of Unstable, Extraarticular Colles Fractures of the Distal Radius by Palmar Locking Plate, External Fixator or Kirschner Wires

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (planned)
• Sponsor: Heinrich-Heine University, Duesseldorf · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colles' Fracture
• Radius Fractures

Interventions

Type	Name	Description
PROCEDURE	Osteosynthesis with palmar locking plate
PROCEDURE	Osteosynthesis with external fixator
PROCEDURE	Osteosynthesis with Kirschner wires

Timeline

• Start date: 2005-11-01
• First posted: 2006-01-04
• Last updated: 2007-04-27

Locations

1 site across 1 country: Germany