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

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ClinicalTrials.gov Identifier: NCT00271726
Recruitment Status : Unknown
Verified April 2007 by Heinrich-Heine University, Duesseldorf.
Recruitment status was:  Recruiting
First Posted : January 4, 2006
Last Update Posted : April 27, 2007
Sponsor:
Collaborator:
Philipps University Marburg Medical Center
Information provided by:
Heinrich-Heine University, Duesseldorf

Study Description
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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.


Condition or disease Intervention/treatment Phase
Colles' Fracture Radius Fractures Procedure: Osteosynthesis with palmar locking plate Procedure: Osteosynthesis with external fixator Procedure: Osteosynthesis with Kirschner wires Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2005

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U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Functional status measured by DASH questionnaire

Secondary Outcome Measures :
  1. Pain
  2. Range of motion (ROM)
  3. Grip strength
  4. Radiological parameters
  5. Feasibility

Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00271726     History of Changes
Other Study ID Numbers: OTEC Pilot 1 KKS MR
First Posted: January 4, 2006    Key Record Dates
Last Update Posted: April 27, 2007
Last Verified: April 2007

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
Fracture Dislocation
Joint Dislocations
Bone Diseases
Musculoskeletal Diseases