MedTrace Logo

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

NCT00271726 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2007-04-27

No results posted yet for this study

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

PROCEDURE

Osteosynthesis with palmar locking plate

PROCEDURE

Osteosynthesis with external fixator

PROCEDURE

Osteosynthesis with Kirschner wires

Sponsors & Collaborators

  • Philipps University Marburg

    collaborator OTHER

  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Principal Investigators

  • Michael Schädel-Höpfner, MD · Department of Trauma and Hand Surgery, University Hospital, Moorenstrasse 5, D - 40225 Düsseldorf

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00271726 on ClinicalTrials.gov