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

Primary Purpose

Colles' Fracture, Radius Fractures

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Osteosynthesis with palmar locking plate
Osteosynthesis with external fixator
Osteosynthesis with Kirschner wires
Sponsored by
Heinrich-Heine University, Duesseldorf
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colles' Fracture focused on measuring distal radius fracture, extraarticular Colles fracture

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Trauma and Hand Surgery, University HospitalRecruiting

Outcomes

Primary Outcome Measures

Functional status measured by DASH questionnaire

Secondary Outcome Measures

Pain
Range of motion (ROM)
Grip strength
Radiological parameters
Feasibility

Full Information

First Posted
January 3, 2006
Last Updated
April 25, 2007
Sponsor
Heinrich-Heine University, Duesseldorf
Collaborators
Philipps University Marburg Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00271726
Brief Title
Operative Treatment of Extraarticular Colles' Fractures of the Distal Radius (OTEC)
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 Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Heinrich-Heine University, Duesseldorf
Collaborators
Philipps University Marburg Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colles' Fracture, Radius Fractures
Keywords
distal radius fracture, extraarticular Colles fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Osteosynthesis with palmar locking plate
Intervention Type
Procedure
Intervention Name(s)
Osteosynthesis with external fixator
Intervention Type
Procedure
Intervention Name(s)
Osteosynthesis with Kirschner wires
Primary Outcome Measure Information:
Title
Functional status measured by DASH questionnaire
Secondary Outcome Measure Information:
Title
Pain
Title
Range of motion (ROM)
Title
Grip strength
Title
Radiological parameters
Title
Feasibility

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Schädel-Höpfner, MD
Phone
+49 211 8104405
Email
schaedel@uni-duesseldorf.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Schädel-Höpfner, MD
Organizational Affiliation
Department of Trauma and Hand Surgery, University Hospital, Moorenstrasse 5, D - 40225 Düsseldorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Trauma and Hand Surgery, University Hospital
City
Düsseldorf
ZIP/Postal Code
D - 40225
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Schädel-Höpfner, MD
Phone
+49 211 8104405
Email
schaedel@uni-duesseldorf.de
First Name & Middle Initial & Last Name & Degree
Michael Schädel-Höpfner, MD

12. IPD Sharing Statement

Learn more about this trial

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

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