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
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|
|Colles' Fracture Radius Fractures||Procedure: Osteosynthesis with palmar locking plate Procedure: Osteosynthesis with external fixator Procedure: Osteosynthesis with Kirschner wires|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
- Functional status measured by DASH questionnaire
- Range of motion (ROM)
- Grip strength
- Radiological parameters
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
|Contact: Michael Schädel-Höpfner, MD||+49 211 firstname.lastname@example.org|
|Department of Trauma and Hand Surgery, University Hospital||Recruiting|
|Düsseldorf, Germany, D - 40225|
|Contact: Michael Schädel-Höpfner, MD +49 211 8104405 email@example.com|
|Principal Investigator: Michael Schädel-Höpfner, MD|
|Principal Investigator:||Michael Schädel-Höpfner, MD||Department of Trauma and Hand Surgery, University Hospital, Moorenstrasse 5, D - 40225 Düsseldorf|