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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

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 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

Resource links provided by NLM:

MedlinePlus related topics: Arm Injuries and Disorders Fractures

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)
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

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

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 August 18, 2017

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