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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Heinrich-Heine University, Duesseldorf.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Philipps University Marburg Medical Center
Information provided by:
Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT00271726
First received: January 3, 2006
Last updated: April 25, 2007
Last verified: April 2007
History of Changes
  Purpose

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.


Condition Intervention
Colles' Fracture
Radius Fractures
 Procedure: Osteosynthesis with palmar locking plate
Procedure: Osteosynthesis with external fixator
Procedure: Osteosynthesis with Kirschner wires

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • Functional status measured by DASH questionnaire

Secondary Outcome Measures:
  • Pain
  • Range of motion (ROM)
  • Grip strength
  • Radiological parameters
  • Feasibility
Estimated Enrollment: 90
Study Start Date: November 2005
  Eligibility
Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271726

Contacts
Contact: Michael Schädel-Höpfner, MD +49 211 8104405 schaedel@uni-duesseldorf.de

Locations
Germany
Department of Trauma and Hand Surgery, University Hospital Recruiting
Düsseldorf, Germany, D - 40225
Contact: Michael Schädel-Höpfner, MD    +49 211 8104405    schaedel@uni-duesseldorf.de   
Principal Investigator: Michael Schädel-Höpfner, MD         
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Philipps University Marburg Medical Center
Investigators
Principal Investigator: Michael Schädel-Höpfner, MD Department of Trauma and Hand Surgery, University Hospital, Moorenstrasse 5, D - 40225 Düsseldorf
  More Information

ClinicalTrials.gov Identifier: NCT00271726     History of Changes
Other Study ID Numbers: OTEC Pilot 1 KKS MR 
Study First Received: January 3, 2006
Last Updated: April 25, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heinrich-Heine University, Duesseldorf:
distal radius fracture
extraarticular Colles fracture

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Colles' Fracture
 Wounds and Injuries
Forearm Injuries
Arm Injuries

ClinicalTrials.gov processed this record on September 27, 2016