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

This study is currently recruiting participants.

Verified by Heinrich-Heine University, Duesseldorf, April 2007

Sponsors and Collaborators:	Heinrich-Heine University, Duesseldorf Philipps University Marburg Medical Center
Information provided by:	Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:	NCT00271726

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

MedlinePlus related topics: Fractures

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

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
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

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

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

Keywords provided by Heinrich-Heine University, Duesseldorf:

distal radius fracture
extraarticular Colles fracture

Study placed in the following topic categories:

Colles' Fracture
Fractures, Bone
Wounds and Injuries
Forearm Injuries

Disorders of Environmental Origin
Radius Fractures
Arm Injuries

ClinicalTrials.gov processed this record on January 16, 2009