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

Radius Fractures Clinical Trial

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 Fixator or Kirschner Wires

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00271726
• Other study ID #: OTEC Pilot 1 KKS MR
• Status: Recruiting
• Phase: N/A
• First received: January 3, 2006
• Last updated: April 25, 2007
• Start date: November 2005

Study information

• Verified date: April 2007
• Source: Heinrich-Heine University, Duesseldorf
• Contact: Michael Schädel-Höpfner, MD
• Phone: +49 211 8104405
• Email: schaedel[@]uni-duesseldorf.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colles' Fracture
• Fractures, Bone
• Radius Fractures

Intervention

Procedure:
• Osteosynthesis with palmar locking plate

• Osteosynthesis with external fixator

• Osteosynthesis with Kirschner wires

Locations

Country	Name	City	State
Germany	Department of Trauma and Hand Surgery, University Hospital	Düsseldorf

Sponsors (2)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf	Philipps University Marburg Medical Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional status measured by DASH questionnaire
Secondary	Pain
Secondary	Range of motion (ROM)
Secondary	Grip strength
Secondary	Radiological parameters
Secondary	Feasibility