Operative Treatment of Extraarticular Colles' Fractures of the Distal Radius (OTEC)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 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 |
- Functional status measured by DASH questionnaire
- Pain
- Range of motion (ROM)
- Grip strength
- Radiological parameters
- Feasibility

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, Learn About Clinical Studies.
Ages Eligible for Study: | 65 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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 8104405 | schaedel@uni-duesseldorf.de |
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 |
Principal Investigator: | Michael Schädel-Höpfner, MD | Department of Trauma and Hand Surgery, University Hospital, Moorenstrasse 5, D - 40225 Düsseldorf |
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 |