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

Not Applicable

• Conditions: Colles' Fracture; Radius Fractures

• Registration Number: NCT00271726
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

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 Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-01-03
• Study First Submitted QC: 2006-01-03
• Study First Posted: 2006-01-04
• Status Verified: 2007-04
• Last Update Submitted: 2007-04-25
• Last Update Posted: 2007-04-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Isolated, extraarticular, unstable Colles' fracture of the metaphysis of the distal radius (AO type A3)
• Age 65 years or older
• Patient agreed with and signed the "informed consent" form

Exclusion Criteria

• Fractures older than 7 days (more than 1 week between injury and treatment)
• Other injuries of the hand
• Other relevant injuries of the upper extremities
• Open fracture
• Patients with one hand missing
• Clinical or radiological signs of any rheumatoid disease, osteoarthritis, or polyarthritis
• Previous skeletal injury or severe soft tissue injury of the arm
• History of drug or alcohol abuse
• Patients unlikely to cooperate or attend all scheduled visits
• Patients who have participated in any other device or drug clinical trial within the previous month
• Patients with legal incompetence

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Functional status measured by DASH questionnaire

Secondary Outcome Measures

Name	Time	Method
Pain
Range of motion (ROM)
Grip strength
Radiological parameters
Feasibility

Trial Locations

Locations (1)

Department of Trauma and Hand Surgery, University Hospital; 🇩🇪 Düsseldorf, Germany